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

Model Number	MODEL 100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse platform (sn: (b)(4)) was returned to zoll for damaged/broken-off head restraints on the top cover.During functional testing performed on 10 november 2020, the autopulse platform failed the load cell characterization test.During visual inspection of the returned platform, it was observed that the head restraint wires were broken off and detached from the top cover.Also, the front enclosure was noted to be cracked.In addition, the battery lock was observed to be bent.The physical damages appeared to be the characteristics of normal wear and tear and/or user mishandling.The autopulse platform is a reusable device, and was manufactured in november 2012, and it is 8 years old, has exceeded its expected service life of 5 years.The top cover, front enclosure, and the battery lock will be replaced to address the observed issues.The autopulse platform passed the initial functional testing without any fault or error.However, the load cell characterization test revealed that both load cells were out of specification.The root cause of the issue was the defective load cell amplifier as a result of normal wear and tear.The load cell amplifier board will be replaced to remedy the fault.The archive data review showed no discrepancies.Awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for autopulse platform with serial number (b)(4).
Event or Problem Description
During investigation performed on 10 november 2020, the autopulse platform (sn: (b)(4)) failed the load cell characterization test during the functional testing.

• 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: 10925439
• Report Number: 3010617000-2020-01224
• Device Sequence Number: 545978
• Product Code: DRM
• UDI-Device Identifier: 00849111001052
• UDI-Public: 00849111001052
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/30/2020

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: 8700-0740-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1