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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device associated with this complaint has been received, however, the investigation is pending.A follow-up report will be filed when the investigation has been completed.
Event or Problem Description
During the shift check, the autopulse platform (b)(6) repeatedly failed and displayed a message of "pull up lifeband".No patient involvement.
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn (b)(6)) displayed a message of "pull up lifeband" was confirmed during the functional testing but not during the archive data review.Zoll service found encoder drive shaft does not rotate smoothly and exhibits binding and that may have caused the difficulty for the user to pull up the lifeband.The root cause for the observed issue was due to a failure of the integrated encoder gearbox.The autopulse platform passed the initial functional test without any fault or error.A load cell characterization test was performed and confirmed both cell modules are functioning within the specification.Upon further inspection, it was observed that manually raising or lowering the lifeband was difficult due to binding and resistance in the encoder drive shaft, thus confirming the customer complaint.The integrated encoder gearbox needs to be replaced to remedy the reported issue.Waiting for customer approval for service.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for the autopulse platform with sn (b)(6).

• 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: 21602094
• Report Number: 3010617000-2025-00201
• Device Sequence Number: 15757112
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• 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