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 Insufficient Information (4580)

Event Date 02/27/2024

Event Type  malfunction  

Event Description

The autopulse platform (b)(6) displayed a "system error, out of service, revert to manual cpr" error message upon powering up.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.

Manufacturer Narrative

Zoll has not received the platform for investigation.A follow-up report will be submitted when the product is returned, and the investigation has been completed.

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(6) displayed a "system error, out of service, revert to manual cpr" error message was confirmed during the archive data review and functional testing.The root cause of the system error is related to a communication error that caused a latch-up of the processor board.Visual inspection of the returned platform was performed, and no physical damage was observed.During the archive data review, system error 132 (internal watchdog timeout) was observed, thus confirming the reported complaint.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering on, thus confirming the reported complaint.Zoll service personnel used the ap vision software to clear the system error.Upon resetting, the platform was re-evaluated through the run_in test using the test manikin performing 3 tests and 95% large resuscitation test fixture (lrtf) with good known test batteries 2 times without fault or error.Since the processor board was replaced in march 2022 to address the system error that was reported by the customer previously and despite intensive tests, the system error could not be reproduced after resetting.Following the service, the brake gap inspection verified the brake gap was within the specification.A load cell characterization test confirmed that both cell modules function within the specification.The autopulse platform passed the final run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries without fault or error.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaint was reported for the autopulse platform with 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 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 18975683
• MDR Text Key: 338567818
• Report Number: 3010617000-2024-00250
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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 Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2016
• 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