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

Model Number MODEL 100

Device Problem Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

The customer's complaint that the autopulse platform (b)(6) shut off was confirmed during the functional testing and the archive data review.The root cause of the reported complaint was a malfunctioning motor controller board, likely attributed to the device's aging.The autopulse platform was manufactured in 2015.Unrelated to the reported complaint, upon visual inspection, a broken part of the top cover near the on/off button and multiple cracks on the front and bottom enclosures were noted.The observed physical damages appear to be the characteristics of user mishandling, such as a drop.The damaged parts were replaced to address the physical damages.The archive data indicated that around the reported event date, the autopulse platform failed during take-up, displaying user advisory (ua) 28 (loss of clutch connectivity) and ua 29 (loss of brake connectivity), and then shutting off.The motor controller board's built-in monitor circuit detected a loss of connectivity of the brake and clutch driving circuit during active operation, confirming the reported complaint.During functional testing, the autopulse platform stopped after a few compressions due to fault 08 (motor controller fault detected).A technical evaluation of the platform revealed that a malfunctioning motor controller board was the root cause of fault 08 and the customer's reported complaint.Upon replacing the motor controller board, the platform was tested with the large resuscitation test fixture (lrtf) with good known test batteries until discharged without fault or error.The reported complaint of the display and the lights were flashing more than normal was not observed or replicated during the testing at zoll.Following service, the autopulse platform passed the run-in and final tests without fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the autopulse platform with (b)(6).

Event Description

The autopulse platform (b)(6) was deployed, and the lifeband was installed to initiate cpr for a patient in cardiac arrest.The autopulse platform shut off upon pressing the start button.The crew powered up the platform again, and the issue persisted.The crew tried to troubleshoot by replacing lifebands and li-ion batteries.The platform would power on, but the observed issue persisted each time the start button was pressed.Also, while troubleshooting, the crew observed that the display and the lights were flashing more than normal.No further information was provided.The patient's status information was requested, but the customer did not provide a response.

• 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 ; 4084192922
• MDR Report Key: 18963545
• MDR Text Key: 338613440
• Report Number: 3010617000-2024-00248
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• 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