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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

During shift check, the customer reported that the autopulse platform (sn (b)(4)) displayed "system error, out of service, revert to manual cpr " upon powering on.No patient involvement.

Manufacturer Narrative

The report of the autopulse platform (sn (b)(6) displayed a system error, out of service, revert to manual cpr message was confirmed during initial functional testing and archive data review.The root cause of the reported issue was due to the defective drivetrain motor, likely due to a defective component.The autopulse platform failed initial functional testing due to "system error, out of service, revert to manual cpr" error message displayed upon powering on.The drivetrain motor brake assembly air gap was too wide, measured at 0.015", out of the specification (0.008" ± 0.001").The brake gap could not be adjusted and continued to open out of specification.The drivetrain motor was replaced to remedy the error.The archive data indicated a system error 139 (unable to hold compression position) message on the reported event date, thus confirming the reported complaint.Additionally, the archive shows the presence of multiple user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error messages, unrelated to the reported complaint.The load cell characterization test revealed that the load cell2 was under-reporting, likely due to a defective component or harsh impact due to user handling.The observed load cell issue is unrelated to the reported complaint.The defective load cell was replaced to address the user advisory (ua) 07 error.Visual inspection was performed and found no physical damage to the autopulse platform.As part of routine service during testing, the platform was examined and, unrelated to the reported complaint, noted corroded metalized inner surface due to fluid ingresses likely due to user mishandling that required a bio-cleaning and the encoder drive shaft does not rotate smoothly, exhibits binding and resistance.The sticky clutch plate was deburred to address the issue.The cause for the sticky clutch could be due to normal wear and tear.Following the service repair, the autopulse platform 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.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform sn (b)(6).

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10161027
• MDR Text Key: 195424951
• Report Number: 3010617000-2020-00617
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111002530
• UDI-Public: 00849111002530
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• 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: 8700-0740-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1