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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

During preventative maintenance (pm), the autopulse platform sn (b)(6) failed the load cell characterization test.The root cause of the failure was a failed load cell, likely attributed to the age of the platform, failed component, or mishandling such as a drop.The autopulse platform was manufactured in 2018 and is over five years old.Upon visual inspection, missing head restraints on the top cover were noted.Missing head restraints do not render the autopulse platform non-functional.The patient head restraint wire could have been cut to free the patient from the platform, or the user could have been lifting the platform by holding the head restraints.The top cover needs to be replaced to address the customer's complaint.The autopulse platform passed the initial functional testing without error or fault.However, the platform failed the load cell characterization check due to a failed load cell and needs to be replaced.Zoll is awaiting customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaint was reported for the autopulse platform with sn (b)(6).

Event Description

The autopulse platform sn (b)(6) failed the load cell characterization test while servicing at zoll.No patient involvement.

• 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: 18641369
• MDR Text Key: 334559709
• Report Number: 3010617000-2024-00163
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/05/2024

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2018
• 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