# K071073: Solar 8000 and Transport Pro with Patient Data Module

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies
- Decided: May 11, 2007 after 25 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K900598 (1990). 6 ancestors in all.
51 later devices descend from it; 5 cite it directly.
1 of 58 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012467: Solar 8000M System, General Electric Medical Systems Information Techn (2002) Summary page 1.
- K042642: Aware Transport Monitor System (Includes Aware Pod and Aware Transport Monitor), Ge Medical Systems Information Technologies (2004) Summary page 1.

## Most influential descendants
- K092027: Carescape Monitor B850 (2009), 38 descendants of its own
- K102239: Carescape Monitor B650 (2010), 32 descendants of its own
- K132533: Carescape Monitor B450 (2013), 14 descendants of its own
- K131223: Carescape Monitor B650 (2013), 13 descendants of its own
- K190008: Carescape One (2019), 11 descendants of its own

## Recalls of this device
- May 21, 2021 · Class II · Z-2139-2021: Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
- May 18, 2020 · Class II · Z-2424-2020: The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection is turned ON, on the monitor, and if an Automa
- Aug 31, 2018 · Class II · Z-0522-2019: The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
- Jul 13, 2017 · Class II · Z-0202-2018: Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.
- Sep 19, 2014 · Class II · Z-0060-2015: GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monit
- Feb 13, 2014 · Class II · Z-1147-2014: GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patient Monitor Automatic-View-On-Alarm (AVOA) feature. The Solar 8000M/i AVOA feature will stop functioning 
- Jan 27, 2014 · Class III · Z-1095-2014: Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return of Diamondback 360 Coronary Orbital Atherectomy Device (OAD). The device mistakenly contains a saline li
- Dec 16, 2013 · Class II · Z-0648-2014: GE Healthcare has recently become aware of a potential safety issue which affects all Patient Date Modules produced from April 2007 through June 2010, encompassing Fiscal Week 13, 2007 through 26, 201
- Dec 5, 2013 · Class II · Z-0807-2014: Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respiration and arrhythmia d
- Nov 27, 2013 · Class II · Z-0747-2014: GE Healthcare has recently become aware of a potential safety issue due to intermittent failure of the spring loaded mounting latch of PDMs produced from April 2007 through December 2012.
- Apr 3, 2013 · Class II · Z-2116-2013: GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/o
- Feb 17, 2012 · Class II · Z-0524-2013: GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.
- Oct 5, 2010 · Not classified · Z-0363-2011: Transport Pro Monitor stops communication with the CARESCAPE Patient Data Module (PDM) after 414 days of continuous run time. This time will equate to different amounts of real time depending on how m

## Indications for use
The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, general intensive care unit (ICU), critical care unit, surgical intensive care unit ISICU), respiratory intensive care unit, coronary care unit fCCU), medical intensive care unit (MICUI, pediatric intensive care unit (PICU), or neonatal intensive care unit (NICU). The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired bythe PDM includes ECG, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. The Transport Pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Patient Data Module (PDM) or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature and respiration. Both the PDM and TRAM acquisition module acquire, process and store information for all aforementioned parameters. The Solar 8000i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000i patient monitoring system is capable of monitoring and analyzing the following parameters for all patient populations: electrocardiogram, invasive pressure, non-invasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous pO2 and pCO2, C02 and respiratory mechanics. The Solar 8000i patient monitoring system is capable of monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, 02, impedance cardiography, electroencephalography and bispectral index. The Solar 8000i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and/or analog data outputs. Information from these devices can be displayed. trended and stored in the monitoring system. The Solar 8000i patient monitoring system also provides physiological data over the UNITY NETWORK TM .

Source page: https://510kreport.com/device/K071073
Methodology: https://510kreport.com/methodology