CHANGE HEALTHCARE CARDIOLOGY HEMO 14.1.1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-20 for CHANGE HEALTHCARE CARDIOLOGY HEMO 14.1.1 manufactured by Change Healthcare Israel Ltd.

Event Text Entries

[180096750] The reporting facility stated that the device did not cause or contribute to the death of the patient. Initial investigation revealed the root cause of the reported malfunction is associated with the hardware components of the device. The hardware components were replaced, and then monitored by the reporting facility. The reporting facility confirmed the rt monitor is working as designed since the replacement. The hardware associated with the failure is under further investigation. Change healthcare will provide a follow up report to the agency once additional information is available.
Patient Sequence No: 1, Text Type: N, H10


[180096751] It was reported that during a procedure in the catheterization lab involving a patient in full cardiac arrest undergoing cpr, defibrillation, and artificial ventilation, that the rt monitor went blank multiple times and rebooted for several seconds and returned to full functionality. During the procedure and the reported rt monitor blanking out events, as indicated in the device instructions for use auxiliary devices were used to monitor the patient's vital signs. Subsequent to the procedure the patient expired.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616760-2020-00002
MDR Report Key9731301
Report SourceOTHER
Date Received2020-02-20
Date of Report2020-02-20
Date of Event2020-01-22
Date Mfgr Received2020-01-22
Device Manufacturer Date2019-01-16
Date Added to Maude2020-02-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. CHESTER MCCOY
Manufacturer Street5995 WINDWARD PARKWAY
Manufacturer CityALPHARETTA, GA
Manufacturer CountryUS
Manufacturer Phone3382088
Manufacturer G1CHANGE HEALTHCARE ISRAEL LTD.
Manufacturer Street26 HAROKMIM ST. AZRIELI CENTER BUILDING A
Manufacturer CityHOLON HAMERKAZ, ISRAEL 5885849
Manufacturer CountryIS
Manufacturer Postal Code5885849
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCHANGE HEALTHCARE CARDIOLOGY HEMO
Generic NameCHANGE HEALTHCARE CARDIOLOGY HEMO
Product CodeDQK
Date Received2020-02-20
Returned To Mfg2020-01-28
Model Number14.1.1
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCHANGE HEALTHCARE ISRAEL LTD
Manufacturer Address26 HAROKMIM ST. AZRIELI CENTER BUILDING A HOLON HAMERKAZ, ISRAEL 5885849 IS 5885849


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-02-20

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