MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The report of the autopulse platform (sn (b)(4)) displaying a system error, out of service, revert to manual cpr message was confirmed during functional testing and archive data review.The root cause is due to a communication error between the drive train motor and the processor board.Visual inspection of the returned platform was performed and found no physical damage.Evaluation of the platform during initial power up, revealed a system error, out of service, revert to manual cpr message, confirming the reported event.Review of archive data revealed latch error 71 (motor drive train command issue) system error.The platform was connected to the autopulse vision software and the error message was able to be cleared.Following this, the platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged without any fault or error.The platform passed all functional tests and is ready for clinical use.Historical complaints were reviewed for service information related to the reported complaint and there was no similar history of complaint reported for autopulse with serial number (b)(4).
Event or Problem Description
The autopulse platform (sn (b)(4)) displayed a "system error, out of service, revert to manual cpr" message upon power up.The reporter was unable to specify if the issue occurred during shift check or patient use.No known impact or patient consequence was reported.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8773594
• Report Number: 3010617000-2019-00631
• Device Sequence Number: 1489112
• Product Code: DRM
• UDI-Device Identifier: 00849111000116
• UDI-Public: 00849111000116
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1