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 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

The customer's complaint that the autopulse platform (b)(6) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) message was confirmed during the functional testing and the archive data review.The root cause of the ua45 advisory message was that the driveshaft was not in the "home" position.Upon visual inspection, no physical damage was noted.The archive data indicated multiple ua45 messages, confirming the reported complaint.Further archive review indicated multiple ua02 (compression tracking error) and ua17 (max motor on time exceeded during active operation) messages unrelated to the reported complaint.During functional testing, the autopulse platform displayed ua45 upon powering on, confirming the reported complaint.Upon further inspection, stiff/stuck manual rotation of the drive shaft was noted.The driveshaft was rotated to the "home" position to clear the ua45.The autopulse platform passed 30:2 and continuous compression tests with normal manikin for 40 minutes and large heavy manikin for 45 minutes.A load cell characterization test confirmed that both cell modules function within the specification.Further investigation of the drive train motor, clutch, encoder, and brake area is pending.A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that the autopulse platform (b)(6) ) displayed user advisory (ua) 45 (not at "home" position after power-on/restart).The shaft was stuck solid 90 degrees from the home position with the lifeband clip still in place.The customer followed the on-screen prompts to reset the shaft, but it wouldn't rotate to the home position to release the lifeband clip.The customer got the shaft to rotate sometime later using a pair of mole grips, allowing the lifeband clip to be removed.However, the ua45 message appeared upon replacing the lifeband.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.

Manufacturer Narrative

Zoll further investigated the drive train motor, clutch, encoder, and brake area.The investigation revealed a malfunctioning drive train motor as the root cause of the observed stiff/stuck manual rotation of the drive shaft and the repeated combination of ua17 and ua2 in the archive.The drive train motor was replaced to address the observed problems.Following 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 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 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 ; 4084192922
• MDR Report Key: 19005280
• MDR Text Key: 338945946
• Report Number: 3010617000-2024-00278
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• 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