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 Consequences Or Impact To Patient (2199)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "the autopulse platform (sn: (b)(4)) displayed "system error, out of service, revert to manual cpr" error message" was confirmed during the functional testing and based on the archive data review.The root cause for the reported complaint was due to the drive train motor brake gap being out of specification as a result of normal wear and tear.The autopulse platform is a reusable device and was manufactured in august 2011, and it is almost 9 years old, well beyond its expected service life of 5 years.During visual inspection of the returned platform, it was observed that one of the head restraint wires was broken off.Also, the front enclosure was observed cracked.The observed physical damages were unrelated to the reported complaint, and the root cause could be due to normal wear and tear or could be due to user mishandling.The front enclosure and head restraint wire should be replaced to remedy the faults.In addition, it was observed that the encoder drive shaft could not rotate smoothly, exhibiting binding and resistance.The probable root cause for this issue is most likely due to sticky driveshaft clutch area, which is usually caused by sharp edges from all 12-hex edges of the armature plate or due to burrs on the surface of the clutch rotor, likely attributed to normal wear and tear.The sticky clutch plate should be deburred to address the issue.The archive data review revealed that the autopulse platform was used on a patient on the customer's reported event date.Review of the archive showed system error user advisory (ua) 139 (unable to hold compression position) message to have occurred on the reported event date; thus, confirming the reported complaint.The autopulse platform failed initial functional testing due to "system error, out of service, revert to manual cpr" error message displayed upon powering up the device.Therefore, the reported complaint was confirmed.The drive train motor brake gap should be adjusted within the specification to remedy the system error.Waiting customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for autopulse with serial number (b)(4).
Event or Problem Description
The autopulse platform (sn: (b)(4)) displayed "system error, out of service, revert to manual cpr" error message upon powering up.No further information was provided on whether the error occurred during shift check or patient use.No consequences or impact to patient.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 9965569
• Report Number: 3010617000-2020-00373
• Device Sequence Number: 14138323
• Product Code: DRM
• UDI-Device Identifier: 00849111001212
• UDI-Public: 00849111001212
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (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): 04/15/2020

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: 8700-0740-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1