MAUDE Adverse Event Report: ZOLL CIRCULATION INC AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the autopulse platform (b)(4) for investigation.A supplemental report will be filed when the product is returned and the investigation has been completed.
Event or Problem Description
As reported, the autopulse platform (b)(4) displayed ua16 (timeout moving to take-up position) error message and the user was unable to clear the error message.No known impact or consequence to patient information was available.
Additional Manufacturer Narrative
The reported event of "the autopulse platform (sn (b)(4) displayed ua16 (timeout moving to take-up position) error message" was confirmed during functional testing and archive data review.The root cause was due to a seized brake gap.Upon visual inspection, noticed damage on the front enclosure of the platform, unrelated to the reported complaint.The front enclosure was replaced to remedy the issue.The physical damage appear to have been caused by user mishandling.The platform failed initial functional testing due to ua16 (timeout moving to take-up position) error message.The archive data review showed occurrence of ua16 error message on the customer reported event date.The root cause was due to a seized brake gap.Brake gap was cleaned and adjusted to remedy the fault.Following the 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.The brake gap inspection was performed and verified the brake gap was within the specification.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).
Event or Problem Description
As reported, during shift check, the autopulse platform (sn (b)(4) displayed ua16 (timeout moving to take-up position) error message and the user was unable to clear the error message.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 8374947
• Report Number: 3010617000-2019-00155
• Device Sequence Number: 1973460
• Product Code: DRM
• UDI-Device Identifier: 00849111001113
• UDI-Public: 00849111001113
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

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: 8700-0740-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1