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	12/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During device check, the autopulse platform (sn (b)(4) ) displayed user advisory (ua) 41 (patient temperature sensor failure) error message.The user was unable to clear the ua41 error message.No patient involvement.
Event or Problem Description
During device check, the autopulse platform (sn (b)(4) ) displayed user advisory (ua) 41 (patient temperature sensor failure) error message.No patient involvement.
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn (b)(6)) displayed a user advisory (ua) 41 (patient temperature sensor failure) error message was confirmed based on the archive data review but not confirmed during the functional testing.No device malfunction was observed that could have caused or contributed to the reported ua41 error message.The storage conditions are not known; however, factors such as ambient storage condition (e.G.A fire truck sitting in a hot and humid environment and/or being exposed to direct sunlight for long hours) as well as using the platform on a soft surface that may block air vents will increase the internal temperature of the autopulse platform and can cause the occurrence of a ua41 error message.Upon visual inspection, unrelated to the reported complaint, cracked front enclosure was observed likely due to user mishandling such as a drop.The damaged front enclosure was replaced to address this issue.In addition, unrelated to the reported complaint, the encoder drive shaft does not rotate smoothly, exhibits binding and resistance due to a sticky clutch plate.The sticky clutch plate was deburred to address the issue.The cause for the sticky clutch could be due to normal wear and tear.The impact of a sticky clutch was not severe enough to make the platform non-functional.The autopulse platform was manufactured in 2013 and is more than 7 years old, past the expected service life of 5 years.A review of the autopulse platform archive was performed, and it showed multiple ua41 (patient temperature sensor failure) error messages to have occurred around the customer's reported event date; thus, confirming the reported complaint.The temperature sensor was replaced as a precautionary measure to address the reported complaint.The autopulse platform passed initial functional testing without any fault or error, and therefore, the reported complaint could not be replicated.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.

• 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: 11121302
• Report Number: 3010617000-2021-00006
• Device Sequence Number: 677149
• Product Code: DRM
• UDI-Device Identifier: 00849111001090
• UDI-Public: 00849111001090
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/19/2021

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: 8700-0740-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1