MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. AUTOPULSE®RESUSCITATION SYSTEM; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn (b)(6)) displayed fault 41 (patient temperature sensor failure) was not confirmed during the functional test but was confirmed during the archive data review.No device malfunction was observed during the functional testing and the autopulse platform performed as intended.The archive data review indicated fault 41, thus confirming the reported complaint.The autopulse platform passed the initial functional test without any fault or error and the reported complaint could not be reproduced.Nevertheless, the temperature sensor needs to be replaced as a preventive precautionary measure, as the sensor may have had some intermittent technical problems that could not be directly identified during the functional testing.A load cell characterization test confirmed that both cell modules function within the specification.Service was not performed, as the customer declined the repair.The autopulse platform will be returned to the customer unrepaired and clearly labeled "not for human use".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 or Problem Description
As reported, the autopulse platform (sn (b)(6)) displayed a fault 41 (patient temperature sensor failure) message.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.

• Brand Name: AUTOPULSE®RESUSCITATION SYSTEM
• Common Device Name: CARDIAC RESUSCITATOR, LINE-POWERED
• Manufacturer (Section D): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 21132725
• Report Number: 3010617000-2025-00021
• Device Sequence Number: 15155140
• Product Code: DRM
• UDI-Device Identifier: 00849111001076
• UDI-Public: 00849111001076
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2025

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
• Operator of Device: Health Professional
• Device Model Number: 100
• Device Catalogue Number: 8700-0740-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown