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 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

The reported event 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 reported issue was due to a software logic related fault resulting in a failed communication between the drive train motor and the processor board.No physical damage was observed during the visual inspection.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 to reset the software and clear the error message.The archive data revealed a system error 132 (internal watchdog timeout) message on the reported event date.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 was no previous history of complaint for autopulse platform with sn (b)(4).

Event Description

As reported, during shift check, the autopulse platform (sn (b)(4)) displayed " system error, out of service, revert to manual cpr" error message.No patient involvement.

• 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: 8344026
• MDR Text Key: 136856282
• Report Number: 3010617000-2019-00084
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000130
• UDI-Public: 00849111000130
• 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

• 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: 8700-0700-08
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2013
• 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