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	05/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn: (b)(4)) displayed "system error, out of service, revert to manual cpr" error message was confirmed based on review of the archive data and during the functional testing.The root cause for the reported complaint was due to a communication error between the drivetrain motor and the processor board.There was no physical damage observed on the returned autopulse platform during the visual inspection.The archive data review revealed that the autopulse platform was not used to compress either patient/object on the reported event date.The archive data review showed the occurrence of system error - user advisory (ua) 132 (internal watchdog timeout) on the reported event date; thus, confirming the reported complaint.The autopulse platform failed initial functional testing due to "system error, out of service, revert to manual cpr" error message displayed upon powering up the device.Therefore, the reported complaint was confirmed.The platform was connected to the autopulse vision software, and the error message was cleared.Unrelated to the reported complaint, it was noted that the drivetrain motor brake gap was too wide, out of the specification, measured at 0.011" (0.008" ± 0.001").The probable root cause for the observed issue was due to normal wear and tear.The autopulse platform is a reusable device and was manufactured in march 2013 and has exceeded its expected service life of 5 years.The drivetrain motor brake gap was adjusted within the specification to address the issue.Following service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for autopulse with serial number (b)(4).
Event or Problem Description
As reported, the autopulse platform (sn: (b)(4)) displayed "system error, out of service, revert to manual cpr" error message.No further information was provided by the customer.Patient use information was requested, but no additional information was provided; therefore, patient use is unknown.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10256104
• Report Number: 3010617000-2020-00665
• Device Sequence Number: 3485261
• Product Code: DRM
• UDI-Device Identifier: 00849111000536
• UDI-Public: 00849111000536
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/09/2020

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: 8700-0730-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1