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

Model Number	MODEL 100
Medical Device Problem Codes	Use of Device Problem (1670); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2021, the returned autopulse platform (b)(4) was serviced for preventive maintenance (pm).The autopulse platform passed initial functional testing without any fault or error.However, 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 may 2014 and it is more than 7 years old, well beyond the expected service life of 5 years.In addition, during further functional testing, the autopulse platform displayed fault code 16 (timeout moving to take-up position) error message due to a defective drive train motor likely due to normal wear and tear.The drive train motor was replaced to remedy the fault.During visual inspection, the top cover, the front enclosure was observed with cracks and the belt clip retention disc was damaged.This type of physical damage on the platform was likely attributed to mishandling such as a drop.The top cover, front enclosure, and the belt clip retention disc were replaced to remedy the physical damages on the platform.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 stiff manual rotation of the driveshaft was noted on the autopulse platform (b)(4).In addition during further testing, the platform failed the functional test due to the fault code 16 (timeout moving to take-up position).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: 12486181
• Report Number: 3010617000-2021-00884
• Device Sequence Number: 4030303
• 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: 02/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• 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