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

Model Number	MODEL 100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the autopulse platform serial # (b)(4) does not retract the lifeband was confirmed during functional test.The root cause of the reported complaint was due to a sticky clutch plate.The sticky clutch was likely attributed to normal wear and tear.The autopulse platform was manufactured in august 2013 and it is nearly 8 years old, past beyond its expected serviceable life of five (5) years.No physical damage was observed on the autopulse platform during visual inspection.During the initial functional testing noticed that the drive shaft clutch was hard to rotate, thus confirming the reported complaint.The sticky clutch plate was deburred to address the reported issue.During the load test using the ap vision software, unrelated to the reported complaint, the load sensing system detected a weight or load imbalance between the two load cells.The root cause was due to a defective load cell, likely attributed to mishandling such as a drop or a defective component.The load cell was replaced to remedy the issue.After service repair completion, 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, customer reported that the autopulse platform serial #(b)(4) does not retract the lifeband.Per customer, the platform did not display any error message during the reported event.The customer tested the lifeband with another autopulse platform and the lifeband worked as intended.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: 11861027
• Report Number: 3010617000-2021-00403
• Device Sequence Number: 3560670
• 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): 05/20/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1