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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform (sn (b)(4)) for investigation.A supplemental report will be filed when the product is returned and the investigation has been completed.

Event Description

As reported, during patient use, the autopulse platform (sn (b)(4)) displayed ua07 ((discrepancy between load 1 and load 2 too large) error message.Per user, the platform displayed ua07 error message even after patient use with no weight on the load plate and was unable to clear the error message.The same issue repeated when the user tested the platform with a manikin.Per user, the platform was displaying ua07 error code as soon as it was powered on.No known impact or consequence to patient information was available.

Manufacturer Narrative

The reported event of "the autopulse platform (sn (b)(4) displayed ua07 ((discrepancy between load 1 and load 2 too large) error message" was confirmed during functional testing and archive data review.The root cause for the reported issue was due to the defective load cell.Upon visual inspection, noticed damage on the top cover and the load plate cover, unrelated to the reported complaint.The top cover and the load plate cover were replaced to remedy the issue.The physical damage appear to have been caused by user mishandling.The autopulse platform failed initial functional testing due to ua07 ((discrepancy between load 1 and load 2 too large) error message.The archive data review showed occurrence of multiple ua07 error messages on the reported event date.The load cell was replaced to remedy the issue.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.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.Historical complaints were reviewed for service information related to the reported complaint and there were no similar complaint reported for autopulse platform with serial number (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 8287720
• MDR Text Key: 134455027
• Report Number: 3010617000-2019-00052
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

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
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 03/27/2019
• Supplement Dates FDA Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1