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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

The customer reported a complaint that the autopulse platform ((b)(6) ) displayed a " system error, out of service, revert to manual cpr " error message was confirmed during the functional testing and based on the review of the archive data.The system error was cleared using ap vision software, and it did not replicate during all subsequent testing.Nevertheless, the drive train was replaced as a preventive precautionary measure, as there may have been some intermittent technical issues that could not be directly identified during the functional testing.There was no physical damage observed during the visual inspection.During the archive data review, system error 132 (internal watchdog timeout) was observed, thus confirming the reported complaint.Also, unrelated to the reported complaint, a fault code (ua) 16 (timeout moving to take-up position) error message was observed multiple times in the archive data.The fault code was cleared by the user and was not reproduced during the functional testing.The fault code 16 is an indication that there is an obstruction between the lifeband and the patient or a twisted lifeband.The recommended actions to take for this type of user advisory are: open lifeband, clear obstruction or twist, pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.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.The system error was cleared using ap vision software.The autopulse platform was subjected to a run-in test using the 95% large resuscitation test fixture (lrtf) with two known good test batteries until discharged without any fault or error.In addition, the platform was tested with manikin and running three batteries until discharged without any fault or error.The drive train was replaced as a precaution against the system error.Following the service, the autopulse platform passed the run-in test without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and one similar complaint was reported for the autopulse platform with (b)(6) ccr 46567, was reported on (b)(6)2019 the system error was cleared using ap vision software.

Event Description

During shift check, the autopulse platform (b)(6) displayed a "system error, out of service, revert to manual cpr" error message upon powering up.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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 19047538
• MDR Text Key: 339738429
• Report Number: 3010617000-2024-00280
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• 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 Returned to Manufacturer: 03/25/2024
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2016
• 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