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	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation and service of the autopulse platform (sn (b)(4)) was performed by a zoll trained distributor service technician.The reported complaint of the platform displaying user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) error message was confirmed during the functional testing and in the archive data review.The root cause of the observed ua 7 error was the defective load cells.The defective load cells were likely attributed to mishandling such as a drop or a defective component.Visual inspection of the returned platform was performed, and no physical damage was observed.During functional testing, the autopulse platform displayed a ua 7 error message upon powering up the platform.The root cause was due to the defective load cells.The archive data review showed ua 7 error message, thus confirming the reported complaint.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.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 was no previous history of complaint reported for autopulse platform with serial number (b)(4).
Event or Problem Description
During shift check, the autopulse platform ((b)(4)) displayed user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) error message.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: 11319307
• Report Number: 3010617000-2021-00166
• Device Sequence Number: 790709
• Product Code: DRM
• UDI-Device Identifier: 00849111000659
• UDI-Public: 00849111000659
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 02/11/2021

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: 8700-0730-24
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1