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 Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(4)) displaying a "system error, out of service, revert to manual cpr" error message was confirmed during functional testing and archive data review.The root cause of the issue was due to the communication error from the drive train motor.The autopulse platform is a reusable device and was manufactured in april 2014 and is approaching the expected service life of five years.Evaluation of the platform during initial power-up, revealed a system error, out of service, revert to manual cpr message.The platform was connected to the autopulse vision software and the error message was able to be cleared.No physical damage was observed during the visual inspection.The archive data revealed a system error 139 (unable to hold compression position) message on the reported event date.Following the service, the autopulse was tested functionally and passed successfully with no further issue or faults observed.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint for autopulse with sn (b)(4).

Event Description

As reported, the autopulse platform (sn (b)(4)) displayed an error message "system error, out of service, revert to manual cpr".No additional information was provided.No known impact or patient consequence information was available.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 8343987
• MDR Text Key: 136856439
• Report Number: 3010617000-2019-00109
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• 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: 8700-0740-08
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1