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

Model Number	14.1.1
Medical Device Problem Codes	Computer Software Problem (1112); Application Program Problem (2880); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/22/2020
Type of Reportable Event	Death
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9616760-2020-00002
• Device Sequence Number: 361652
• Product Code: DQK
• UDI-Device Identifier: 17540262100020
• UDI-Public: (01)17540262100020(10)140101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 48 YR