DS1 to Datascp Bln Pump 9.2M

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• • Ongoing Z-2139-2021 FDA Class II ·initiated 21 May 2021

  Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.

• • Ongoing Z-2424-2020 FDA Class II ·initiated 18 May 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 Automated External Defibrillator (AED) is used to perform defibrillation, the low frequency signals deployed by the AED, cause the PDM to issue a false flat line ECG waveform and alarm Asystole to be displayed on the monitor.

• • Ongoing Z-0522-2019 FDA Class II ·initiated 31 Aug 2018

  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.

• • Terminated Z-0202-2018 FDA Class II ·initiated 13 Jul 2017

  Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.

• • Terminated Z-0060-2015 FDA Class II ·initiated 19 Sep 2014

  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 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform an

• • Terminated Z-1147-2014 FDA Class II ·initiated 13 Feb 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 if the patient monitor is discharged from the CIC Central Station while a remote automatic bedside alarm view is currently being displayed on the Solar. Once this issue occurs, subsequent remote AV

• • Terminated Z-1095-2014 FDA Class III ·initiated 27 Jan 2014 ·on shared 510(k) K071073

  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 line that is used in our peripheral atherectomy device. This saline line was not part of the FDA approval for use in the coronary device. It therefore does not meet specification for this device. C

• • Terminated Z-0648-2014 FDA Class II ·initiated 16 Dec 2013

  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, 2010 due to fluid ingress into the top cover assembly which can result in heat buildup.

• • Terminated Z-0807-2014 FDA Class II ·initiated 5 Dec 2013

  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 detection performance.

• • Terminated Z-0747-2014 FDA Class II ·initiated 27 Nov 2013

  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.

• • Terminated Z-2116-2013 FDA Class II ·initiated 3 Apr 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/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance.

• • Terminated Z-0524-2013 FDA Class II ·initiated 17 Feb 2012

  GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.

• • Terminated Z-0363-2011 FDA Unclassified (pre-2012) ·initiated 5 Oct 2010

  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 much the units is actually in service per day. Transport Pro contains an internal timer that is used to control the software and remind users to perform preventive maintenance. When this internal timer

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Generic Name

Electrical-only medical device connection cable, reusable

Device Name

Defib Sync Cables

Model / Reference

2023808-002

Primary DI / UDI-DI

00840682117531

Basic UDI-DI

8406821BUG00026GW

510(k) Number

K071073 ↗

FDA Product Code

MHX

EMDN Code

Z1203020280 Multi-parameter monitors - hardware accessories

GMDN Term

Electrical-only medical device connection cable, reusable

Device Class

Class I EUDAMED

Class II GUDID

Regulation Number

870.1025

EU market of registration

France

GUDID distribution status

In Commercial Distribution

MRI Safety

MR Unsafe

EUDAMED SRN

US-MF-000017529

Authorised representative

GE Medical Systems SCS FR-AR-000000344

• Carescape Central Station MAI800

  Class II

  CE/MDR GUDID on market

• CareIntellect Perinatal 2.3

  Class II

  GUDID on market

• CARESCAPE Telemetry Server V6

  Class II

  GUDID on market

• ComboLab AltiX XI

  Class II

  CE/MDR GUDID on market

• Mac-Lab AltiX XI

  Class II

  CE/MDR GUDID on market

• MLCL Client Software AltiX XI

  Class II

  CE/MDR GUDID on market

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