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	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.
Event or Problem Description
During shift check, customer reported that the autopulse platform (serial #(b)(4)) displayed "system error, out of service, revert to manual cpr " upon powering on.Error message could not be cleared by the user.No patient involvement.
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (serial #(b)(6) displayed "system error, out of service, revert to manual cpr " error message was confirmed based on review of the archive data and during the functional testing.The root cause of the reported complaint was due to a communication error between the drive train motor and the processor pca board.Visual inspection of the returned platform was performed, and no physical damage was observed.During archive data review, system error 71(motor drive train command issue) was identified.Thus, confirming the reported complaint.The autopulse platform failed initial functional testing due to "system error, out of service, revert to manual cpr" error message displayed upon powering on, thus confirming the reported complaint.To remedy, the autopulse platform was connected to the ap vision 3 software to clear the system error message.In addition, during further functional testing, unrelated to the reported issue, found the encoder drive shaft does not rotate smoothly, exhibits binding and resistance due to a sticky clutch plate.This issue does not affect the functionality of the device.Deburring of the clutch plate was performed to remedy this issue.After service completion, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with a good known test battery until discharged without any fault or error.The autopulse platform passed all functional tests.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint 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: 10939751
• Report Number: 3010617000-2020-01207
• Device Sequence Number: 791649
• Product Code: DRM
• UDI-Device Identifier: 00849111002516
• UDI-Public: 00849111002516
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 01/18/2021

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: 8700-0740-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1