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	12/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (sn (b)(6)) repeatedly failed to recognize the patient, displaying "restart" instead of "continue," and could not initiate compressions was confirmed during the archive data review and functional testing.Based on the archive data, the autopulse platform displayed the user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message, failing to provide compressions.The root cause of the ua07 was due to the failure of both load cells, likely attributed to failed components.During visual inspection, unrelated to the reported complaint, a cracked front enclosure was observed.The observed physical damage appeared to be the characteristic of mishandling.The front enclosure was replaced to address the issue.The archive data indicated several (ua) 07 errors around the reported event date, thus confirming the customer's reported complaint.The autopulse platform passed the initial functional testing without any fault or error.Upon further testing, the autopulse platform failed the load cell characterization test as both load cell modules were exceeding normal parameters, unrelated to the reported complaint.The failed load cell modules were replaced to address the observed failure.Following service, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries without any fault or error.A load cell characterization test was performed and confirmed that both cell modules function within the specification.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for the autopulse platform with sn (b)(6).
Event or Problem Description
During patient resuscitation, the autopulse platform (sn (b)(6) repeatedly failed to recognize the patient, displaying "restart" instead of "continue," and could not initiate compressions.Initially, this issue was mitigated by bending the patient's knees to increase the lumbar contact surface.However, the problem recurred after each rhythm check, leading to delays and difficulty in resolution.Upon reassessment in the ambulance, the device's malfunction persisted despite various interventions, including patient repositioning, restarting the autopulse platform, and replacing the battery.Ultimately, manual chest compressions were performed during transport to the hospital.The patient's status is unknown.After the call, autopulse platform testing revealed no problems, as it functioned normally with a resuscitation manikin.

• 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: 21329265
• Report Number: 3010617000-2025-00090
• Device Sequence Number: 12882949
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/06/2025

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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2015
• 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
• Patient Weight: 100 KG