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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281)

Patient Problem Insufficient Information (4580)

Event Date 11/15/2023

Event Type  malfunction  

Event Description

During the patient call, the autopulse platform (b)(6) stopped compression and displayed a user advisory (ua) 07 (discrepancy between load 1 and load 2 too large).No further information was provided.The patient's status information was requested, but the customer did not provide a response.

Manufacturer Narrative

The customer's complaint that the autopulse platform (b)(6) stopped compression and displayed a user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) message was confirmed during the functional testing and the archive data review.The root cause of the ua07 was due to a failed load cell.The cracked enclosure and a load cell failure were likely attributed to mishandling, such as a drop, or the age of the platform.The autopulse platform was manufactured in 2010 and is over 13 years old, well past the expected serviceable life of five years.Unrelated to the reported complaint, a crack across the screw well area of the front enclosure handle, a large hole and crack on the load plate cover, a bent battery lock, and a frayed head restraint were noted upon visual inspection.The observed physical damages appear to be the characteristics of the harsh impact caused by user mishandling, such as a drop.The damaged parts were replaced to address the observed physical damages.The archive data indicated several ua07 on and around the reported event date, confirming the reported complaint.The autopulse platform failed initial functional testing due to a ua07 error message, confirming the reported complaint.The load cell characterization check revealed a failed load cell, which was replaced to address the reported ua07 error.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 no similar complaint was reported for the autopulse platform with (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 thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18298309
• MDR Text Key: 330140271
• Report Number: 3010617000-2023-01033
• 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: 12/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2023
• 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: 11/30/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2010
• 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