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	01/28/2020
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, when the autopulse platform (sn: (b)(4)) was powered on, the lifeband (lot # unknown) did not retract to start compressions, and fault code 16 (timeout moving to take-up position) was displayed on the platform.The user re-adjusted the lifeband and pressed the restart button to clear the fault code; however, the issue was not resolved.No patient involvement.Please see the following related mfr report: mfr # 3010617000-2020-00257 for the lifeband (lot # unknown).
Additional Manufacturer Narrative
H4 (device manufacture date) was updated.The reported complaint of "the lifeband did not retract to start compressions and the autopulse platform (sn: (b)(6) displayed fault code 16 (timeout moving to take-up position) error message upon powering up" was confirmed during functional testing and archive data review.The root cause for the reported complaint was due to the drivetrain motor brake gap was out of specification.The brake gap was adjusted to remedy the fault.During visual inspection, there was no physical damage observed on the returned autopulse platform.The archive data was recovered but was unable to be converted to an excel format.However, the recovered data revealed multiple fault code 16 (timeout moving to take-up position) error messages; thus, confirming the reported complaint.The autopulse platform failed the initial functional testing due to the fault code 16 error message when the platform was powered on; thus, confirming the reported complaint.During further device evaluation, unrelated to the reported complaint, it was noted that the load cell interface cable was pinched.It appeared that the insulation of the cable was breached, but the wires inside were intact.The damaged cable will be replaced to address the issue.Waiting customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse with serial number (b)(6).

• 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: 9741996
• Report Number: 3010617000-2020-00159
• Device Sequence Number: 11216276
• Product Code: DRM
• UDI-Device Identifier: 00849111002516
• UDI-Public: 00849111002516
• 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,Followup
• Report Date (Section B): 05/08/2020

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: 04/07/2020
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1