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 Patient Involvement (2645)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.
Event or Problem Description
During shift check, customer reported that the autopulse platform (serial # (b)(4)) displayed "system error, out of service, revert to manual cpr " upon powering on.Error message could not be cleared by the user.No patient involvement.
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (serial # (b)(4) displayed "system error, out of service, revert to manual cpr" message was confirmed during functional testing and archive date review.The investigation findings revealed the drive train motor brake assembly air gap was too wide, out of specification.Therefore, the root cause of the reported system error was due to a damaged drive train motor.Unrelated to the reported complaint, a cut patient wire restraint was observed on the autopulse platform during visual inspection in which was likely due to user error.The top cover need to be replaced to remedy the cut wire restraint.Also observed, the encoder drive shaft does not rotate smoothly, exhibits binding and resistance due to a sticky clutch plate.The faulty shaft was due to wear and tear.The returned autopulse platform is nearing its expected serviceable life of 5 years, it was manufactured in december 2015.To remedy clutch plate, deburring need to performed.During archive data review, system error latch 139 (unable to hold compression position (system error)) was observed.Thus, confirming the reported complaint.The initial functional test failed due to returned autopulse platform displayed "system error, out of service, revert to manual cpr" during power on.Thus, confirming the reported complaint.To remedy the system error, the damaged drive train motor need to be replaced.Awaiting customer's approval for service repair.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaints reported for autopulse with serial number (b)(4).Ccr (b)(4) reported on (b)(6) 2017.Autopulse platform displayed "system error, out of service, revert to manual cpr" message due to damaged drive train motor.Drive train motor was and will be replaced to remedy the issue.

• 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: 9931587
• Report Number: 3010617000-2020-00409
• Device Sequence Number: 14423560
• Product Code: DRM
• UDI-Device Identifier: 00849111002530
• UDI-Public: 00849111002530
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 05/06/2020

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: 8700-0740-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1