MAUDE Adverse Event Report: CHANGE HEALTHCARE ISRAEL LTD CHANGE HEALTHCARE CARDIOLOGY HEMO

Model Number 14.1.1

Device Problems Computer Software Problem (1112); Application Program Problem (2880); Unintended Application Program Shut Down (4032)

Patient Problem Death (1802)

Event Date 01/22/2020

Event Type  Death  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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, as the hardware components were replaced, and no recurrence of this incident was reported by the reporting facility.Testing of pb-1000, one of the hardware components associated with the failure, concluded that it is within its specifications.The other hardware component (cu) was not received by change healthcare, despite a replacement unit that was sent to the customer.Multiple follow up attempts were made by phone and by email.Therefore, the cu component associated with the failure was not inspected.Due to the above, to date, change healthcare cannot determine the root cause of the failure.If additional information will be obtained, change healthcare will follow up with fda.

Event Description

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.

• Brand Name: CHANGE HEALTHCARE CARDIOLOGY HEMO
• Type of Device: CHANGE HEALTHCARE CARDIOLOGY HEMO
• Manufacturer (Section D): CHANGE HEALTHCARE ISRAEL LTD; 26 harokmim st.; azrieli center building a; holon hamerkaz, israel 58858 49; IS 5885849
• MDR Report Key: 9731301
• MDR Text Key: 180096750
• Report Number: 9616760-2020-00002
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 17540262100020
• UDI-Public: (01)17540262100020(10)140101
• Combination Product (y/n): N
• PMA/PMN Number: K131497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 14.1.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 48 YR