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 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform sn (b)(6) "displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message" was confirmed during the initial functional testing and archive data review.The root cause of the (ua) 07 was due to the failed load cell module.The damaged front enclosure and failed load cell were likely attributed to mishandling such as a drop.The load cell was replaced to remedy the fault.Upon visual inspection, unrelated to the reported complaint, observed a cracked front enclosure, likely attributed to user mishandling, such as a drop.The front enclosure was replaced to remedy the problem.A review of the archive data showed multiple (ua) 07 error messages to have occurred around the customer's reported event date, thus confirming the reported complaint.The autopulse platform failed the initial functional testing due to the (ua) 07 error message displayed upon powering on, thus confirming the customer complaint.During the power-on-self-test, the load sensing system detected a weight or load imbalance between the two load cells.The load cell characterization test results confirmed a failed load cell module 2.The load cell module 2 was replaced to remedy the (ua) 07 error.The autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries for 15 minutes without any fault or error.A load cell characterization test was performed and confirmed that both cell modules function within the specification.Waiting on the customer's approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for the autopulse platform with sn (b)(6).

Event Description

As reported, the autopulse platform sn (b)(6) displayed a user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) message that could not be cleared.No further information was provided.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.

• 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: 18189283
• MDR Text Key: 328745742
• Report Number: 3010617000-2023-00982
• 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

• 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: 11/08/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2020
• 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