MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; 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	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's reported complaint of the autopulse platform displayed user advisory (ua) 28 (loss of clutch connectivity) error message was confirmed in the archive review but not during the initial functional testing.The faulty power distribution board (pdb) was replaced to remedy the fault.Review of the archive data indicated user advisory (ua) 28 errors occurred around the reported event date, thus confirming the reported complaint.As part of routine service during testing, the platform was examined and unrelated to the reported complaint, encoder drive shaft does not rotate smoothly, exhibits binding and resistance and the backlight of lcd is not functional.The sticky clutch plate was deburred and the lcd was replaced to address the issue.The platform was further tested using the manikin with lrtf (large resuscitation test fixture) with continuous compressions with a good known test battery until discharged and passed with no issue or faults observed.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for autopulse platform (b)(4).
Event or Problem Description
It was reported that during a shift check, the autopulse platform ((b)(4)) displayed user advisory (ua) 28 (loss of clutch connectivity) error message.No patient involved with this event.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8254524
• Report Number: 3010617000-2019-00035
• Device Sequence Number: 2463711
• Product Code: DRM
• UDI-Device Identifier: 00849111000574
• UDI-Public: 00849111000574
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2019

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: 8700-0730-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1