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 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform sn (b)(6) would not size the patient and displayed "adjust lifeband".Based on the functional testing and the archive data review performed at zoll, the platform would not size the patient and displayed "adjust lifeband" after the device displayed the user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.The root cause for (ua) 07 was due to a failed load cell.The failed load cell was likely attributed to mishandling such as a drop or a defective component.During visual inspection, there was no physical damage observed on the autopulse platform.As part of routine service during testing, the platform was examined, and unrelated to the reported complaint, the encoder drive shaft does not rotate smoothly and exhibits binding and resistance due to a sticky clutch plate.The cause for the sticky clutch could be due to the normal use of the device.The clutch plate was deburred to remedy the problem.The archive data shows multiple (ua) 07 error messages occurred on the reported event date which was likely the root cause of the displayed "adjust lifeband" error message, thus confirming the reported complaint.During initial functional testing, the autopulse platform displayed a (ua) 07 error message upon powering up.During the power-on-self-test, the load sensing system detected a weight or load imbalance between the two load cells.Load cell characterization results confirmed that load cell module 2 over-reported.The failed load cell module 2 was replaced to remedy the fault.Following the service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was one similar complaint reported for the autopulse platform with sn (b)(6).Ccr 51217 was reported on september 15, 2020.The load cell module was replaced to remedy the issue.

Event Description

As reported, the autopulse platform sn (b)(6) would not size the patient and displayed "adjust lifeband".The customer tried multiple lifebands without success.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: kim nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18189302
• MDR Text Key: 328747778
• Report Number: 3010617000-2023-01002
• 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: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• 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: 11/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2019
• 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