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

Model Number	MODEL 100
Medical Device Problem Codes	Failure to Power Up (1476); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse platform in complaint was returned to zoll on february 28, 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)) kept rebooting after the green start/continue button was pressed.As reported, the battery was fully charged prior to inserting it into the autopulse platform.No patient involvement.
Additional Manufacturer Narrative
The reported complaint of "the autopulse platform (s/n (b)(6) kept rebooting after the green start/continue button was pressed" was confirmed during functional testing.The root cause of the reported complaint was the defective processor board, likely due to a defective component.Visual inspection of the returned autopulse platform was performed, and no physical damage was observed.Archive data could not be downloaded and reviewed because the autopulse platform failed to boot up.The autopulse platform failed functional testing, as the system kept re-starting and failed to boot up; thus, confirming the reported complaint.The processor board (pca) will be replaced to remedy the issue.Awaiting customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse platform 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: 11579838
• Report Number: 3010617000-2021-00249
• Device Sequence Number: 3660034
• Product Code: DRM
• UDI-Device Identifier: 00849111001236
• UDI-Public: 00849111001236
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/09/2021

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: 8700-0740-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 03/27/2021
• Supplement Report FDA Received Date: 04/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1