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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse platform in complaint was returned to zoll on (b)(6) 2021 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
During shift check, the autopulse platform (s/n (b)(4)) displayed a "system error, out of service, revert to manual cpr" error message upon powering up.To troubleshoot, the autopulse was re-started, but the issue was not resolved.During further troubleshooting, the battery was removed and re-inserted back into the platform, but the issue persisted.Lastly, the customer followed other troubleshooting procedures from the administrative menu with no success.No patient involvement.
Additional Manufacturer Narrative
The reported complaint of "the autopulse platform (s/n (b)(6)) displayed 'system error, out of service, revert to manual cpr' error message" was confirmed based on the archive data review and during functional testing.The root cause of the reported complaint was due to the drivetrain motor brake gap being too wide, out of specification, likely attributed to wear and tear.The autopulse platform was manufactured in march 2007, and it is over 14 years old, well beyond its expected service life of 5 years.However, user mishandling/neglect cannot be ruled out as no documented report was found showing that regular preventative maintenance (pm) was performed since the device was acquired by the customer.Performing regular preventive maintenance would prevent the brake gap from exceeding allowable tolerance and causing the autopulse platform to stop functioning with a system error, per design.Visual inspection of the returned autopulse platform showed that the top cover and front enclosure were cracked/damaged, unrelated to the reported complaint.The root cause of the physical damages could be due to user mishandling.The top cover and front enclosure were replaced to address the observed issues.The platform was further examined and unrelated to the reported complaint, it was noted that the power distribution board (pdb) revision level was below 6 and was updated, attributed to the age of the platform.Review of the archive showed a system error user advisory (ua) 139 (unable to hold compression position) message to have occurred around the customer's reported event date; thus, confirming the reported complaint.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering up the device; thus, confirming the reported complaint.Investigation revealed that the drivetrain motor brake gap was too wide, out of the specification.The brake gap could not be adjusted and continued to open out of specification, causing the system error.The drivetrain motor was replaced to remedy the fault.Further functional testing revealed that the encoder driveshaft could not rotate smoothly, exhibiting binding and resistance, unrelated to the reported complaint.The root cause was due to the sticky driveshaft clutch area, which is usually caused by sharp edges from all 12-hex edges of the armature plate, or due to burrs on the surface of the clutch rotor, likely attributed to wear and tear.The drivetrain motor assembly including the clutch was replaced to resolve the issue.During testing, the cooling fan/blower of the autopulse platform was noted to be noisy/loud, unrelated to the reported complaint.This root cause was due to worn ball bearings, likely attributed to wear and tear.The cooling fan assembly was replaced 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 were no similar complaints reported for autopulse with serial number (b)(6).

• 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: 11780760
• Report Number: 3010617000-2021-00384
• Device Sequence Number: 3646860
• Product Code: DRM
• UDI-Device Identifier: 00849111000154
• UDI-Public: 00849111000154
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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: 8700-0700-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1