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 Type  malfunction  

Manufacturer Narrative

The reported complaint that the autopulse platform (sn (b)(6) ) intermittently displays fault 41 (patient temperature sensor failure) was confirmed during the archive data review but not reproduced during the functional testing.The technical investigation revealed that the root cause of the intermittent fault 16 was a malfunctioning temperature sensor, likely attributed to the device's aging.The autopulse platform was manufactured in 2016 and is over seven years old, past the expected serviceable life of five years.Unrelated to the reported complaint, a hairline crack on the front enclosure was noted upon visual inspection.The likely root cause of the observed physical damage was wear and tear or user mishandling.The front enclosure needs to be replaced to address the observed physical damage.The archive data indicated multiple fault 41, confirming the reported complaint.The autopulse platform passes the initial functional testing without error or fault.The brake gap inspection verified the brake gap was within the specification.A load cell characterization test confirmed that both cell modules function within the specification.The temperature sensor needs to be replaced to address the reported complaint.Zoll is awaiting customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the autopulse platform with sn (b)(6).

Event Description

The distributor reported that the customer's autopulse platform (sn 41716) displays fault 41 (patient temperature sensor failure) intermittently.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 thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18067685
• MDR Text Key: 327316278
• Report Number: 3010617000-2023-00936
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2023

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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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