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

Model Number	MODEL 100
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Failure to Power Up (1476); Noise, Audible (3273)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "the autopulse platform [sn (b)(4)] failed to power up" and "the lcd display is not readable and the motor makes a clicking sound " was confirmed during functional testing.The root cause of the reported complaint was the defective processor board, likely as a result of normal wear and tear.The autopulse platform is a reusable device and was manufactured in february 2012, and it is more than 9 years old, well beyond its expected service life of 5 years.Upon visual inspection, the top cover and the front enclosure were observed cracked.The observed physical damages were unrelated to the reported complaint and appeared to be the characteristics of user mishandling such as a drop.The top cover and the front enclosure were replaced to remedy the observed issues.Also, unrelated to the reported issue, 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 impact of the sticky clutch was not severe enough to make the platform non-functional.Unable to recover data archive due to defective processor board.During functional testing, the autopulse platform made a clicking sound and failed to boot up due to the defective processor board, thus confirming the customer's reported complaint.In addition, findings revealed that due to the defective processor board the lcd was not readable, thus confirming the customer's reported complaint.The processor board was replaced to remedy the fault.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.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).Date of event is unknown.
Event or Problem Description
The autopulse platform [sn (b)(4)] failed to power up.The lcd display is not readable and the motor makes a clicking sound.Patient use information was requested but no additional information was provided, therefore patient use is unknown.

• 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: 11449907
• Report Number: 3010617000-2021-00182
• Device Sequence Number: 19612383
• Product Code: DRM
• UDI-Device Identifier: 00849111001090
• UDI-Public: 00849111001090
• Combination Product (Y/N): N
• Initial Reporter Country: LG
• 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,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2021

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: 8700-0740-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1