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 10/10/2023

Event Type  malfunction  

Event Description

As reported, the autopulse platform sn (b)(6) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.The customer attempted troubleshooting by reseting the lifeband, but the ua persisted.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.

Manufacturer Narrative

The customer reported a complaint that the autopulse platform (sn 24647) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message was confirmed during the functional testing and archive data review.The root cause of the (ua) 07 error was due to the failed load cell module, likely attributed to a failed component or mishandling such as a drop.During visual inspection, there was no physical damage observed on the autopulse platform.In addition, unrelated to the reported complaint, the encoder driveshaft of the platform does not rotate smoothly and exhibits binding and resistance due to a sticky clutch plate.This type of driveshaft issue is characteristic of the normal use of the platform.The impact of a sticky clutch was not severe enough to make the platform non-functional.Deburring of the clutch plate needs to be performed to remedy the encoder driveshaft issue.The archive data indicated several (ua) 07 errors around the reported event date, thus, confirming the customer's reported complaint.The autopulse platform failed initial functional testing due to (ua) 07 displayed upon powering on, thus confirming the customer's reported complaint.The load cell characterization test revealed that both load cell modules were over-reporting.The load cell modules need to be replaced to address the reported complaint.Waiting on the customer's approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint 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: kim nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18044566
• MDR Text Key: 327032646
• Report Number: 3010617000-2023-00932
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/31/2023

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• 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