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

Model Number	100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint with the autopulse platform (sn (b)(6) not resuming compressions after being paused was confirmed through archive data and functional testing.Although the customer did not report any user advisory messages or fault codes, the archive data showed multiple instances of user advisory 11 (max patient temperature exceeded) and fault code 41 (patient temperature sensor failure) on the reported event date.Ua11 advisory was replicated during functional testing; however, after removing and reinstalling the temperature sensor, the issue was resolved.The temperature sensor will be replaced as a preventive measure because it caused the intermittent occurrences of fault 41 and ua11 messages, which led to the platform not performing compressions after pressing the start/continue button.The issue with the temperature sensor is likely attributed to the device's aging.The device's life expectancy is 5 years.The autopulse platform was manufactured in june 2015 and is over 10 years old.Zoll is awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaints were reported for the autopulse platform with serial number (b)(6).
Event or Problem Description
The customer reported that during patient use of the autopulse platform (sn (b)(6), they paused the compression and then pressed the start/continue button to resume compressions, but it didn't.The customer did not provide information on why they paused the autopulse platform or whether it displayed any user advisory messages, fault codes, or prompts.After removing and reinstalling the lifeband, the platform was able to resume compressions.The customer's clinical engineer reported that the hinged belt guard on the lifeband was damaged after use.The customer discarded the lifeband but provided a picture that showed that the tyvek liner of the lifeband had detached from the hinged belt guard.It is unknown if there were any consequences or impact on the patient.

• 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: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 22812621
• Report Number: 3010617000-2025-00556
• Device Sequence Number: 21021823
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2015
• 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