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	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During preventive maintenance at the customer site, the autopulse platform (sn (b)(4) ) failed initial functional testing and displayed user advisory (ua) 02 (compression tracking error) error message.The platform was returned to the zoll service depot and the user advisory (ua) 02 was confirmed.The root cause was due to defective load cell, likely due to a defective component or mishandling such as drop.During visual inspection, there was no physical damage observed on the autopulse platform.Also, found the encoder drive shaft does not rotate smoothly, exhibits binding and resistance due to a sticky clutch plate.This type of drive shaft issue is the characteristic of normal wear and tear.Deburring of the clutch plate was performed to remedy the encoder driveshaft issue.The autopulse platform is a reusable device and was manufactured in (b)(6) 2008 and is more than 13 years old, well beyond the expected service life of 5 years.The impact of the sticky clutch was not severe enough to make the platform non-functional.During functional testing, the platform displayed user advisory (ua) 02 error message due to a defective load cell module that was confirmed by the load cell characterization test.The load cell module needs to be replaced to address user advisory (ua) 02 error.Waiting for customer approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for autopulse platform with serial number (b)(4).
Event or Problem Description
During the preventive maintenance at the customer site, the autopulse platform sn (b)(4) displayed user advisory (ua) 02 (compression tracking 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: 11579950
• Report Number: 3010617000-2021-00276
• Device Sequence Number: 11677434
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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: 03/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1