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	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that "the autopulse platform (s/n (b)(4) ) displayed 'system error, out of service, revert to manual cpr' upon powering up" was confirmed during functional testing.Archive review could not be performed because the data could not be downloaded due to the size of the data being over the limit.Therefore, the specific type of system error could not be identified.The brake gap was inspected as a potential root cause for the system error, but investigation results confirmed that the brake gap was within the specification.The system error was cleared using apvision3 software.Nevertheless, the processor board pca assembly was replaced as a preventive precautionary measure.Upon visual inspection, it was noted that the load plate cover was defective with a hole, affecting the watertight seal, unrelated to the reported complaint.This type of physical damage is characteristic of user mishandling.The load plate cover was replaced to address the issue.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 needed to be updated, attributed to the age of the platform.The autopulse platform was manufactured in october 2007 and is over 13 years old, well beyond its expected service life of 5 years.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.After the system error was cleared using the apvision software, the autopulse passed further functional tests without any fault or error.Following service, the autopulse platform passed all testing criteria.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for autopulse platform with serial number (b)(4).
Event or Problem Description
During shift check, the autopulse platform (s/n (b)(4)) displayed "system error, out of service, revert to manual cpr" upon powering up.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: 12218920
• Report Number: 3010617000-2021-00637
• Device Sequence Number: 11522083
• Product Code: DRM
• UDI-Device Identifier: 00849111000079
• UDI-Public: 00849111000079
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 07/23/2021

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: 8700-0700-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1