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

Model Number	MODEL 100
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2021, the returned autopulse platform (b)(4) was serviced for preventive maintenance (pm).During functional testing the platform power off by itself.The root cause was due to the defective power distribution board (pdb) as a result of normal wear and tear.In addition, during further functional testing, the stiff manual rotation of the driveshaft was noted.The clutch area was cleaned, however, the issue persisted requiring the replacement of the defective encoder gearbox likely due to the normal wear and tear.The returned autopulse platform was manufactured in february 2012 and it is more than 9 years old, well beyond the expected service life of 5 years.As part of routine service during testing, the platform was examined and found no physical damages.Following service, the autopulse platform passed 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.A load cell characterization test was performed and confirmed both cell modules are functioning within the specification.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with a serial number (b)(4).
Event or Problem Description
During preventive maintenance on (b)(6) 2021, the autopulse platform (b)(4) powered off during the functional testing.No patient involvement.

• 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: 12486205
• Report Number: 3010617000-2021-00838
• Device Sequence Number: 4030304
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2021

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: 07/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1