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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that "the autopulse platform (sn (b)(6)) displayed "system error, out of service, revert to manual cpr" error message" was confirmed during the functional testing and based on the review of the archive data.The root cause of the error message was due to the drivetrain motor brake assembly air gap being too wide, and out of specification, which is likely attributed to the age of the device.The device life expectancy is 5 years.The autopulse platform was manufactured in january 2011 and is over 14 years old.The archive data review indicated system error - 139 (unable to hold compression position), thus confirming the reported complaint.In addition, the archive noted the presence of the (ua) 17 (max motor on time exceeded during active operation) error message as a result of the drivetrain motor brake assembly air gap being out of specification.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering on, thus confirming the reported complaint.The investigation revealed that the drivetrain motor brake assembly air gap was too wide, which caused the ua139 error.The brake gap could not be adjusted and continued to open out of specification.The investigation found that the motor shaft dimples had widened/worn out.Therefore, the m3-.5 x 4mm set screws would not lock into the drivetrain motor shaft dimple locking well and caused the brake to disengage.The drivetrain motor assembly needs to be replaced to remedy the ua139 error.Waiting for customer approval for 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).B3, the date of the event is unknown.
Event or Problem Description
During the shift check, the autopulse platform (sn (b)(6)) displayed a "system error, out of service, revert to manual cpr" error message.No patient involvement.

• 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: 21981924
• Report Number: 3010617000-2025-00335
• Device Sequence Number: 8572658
• Product Code: DRM
• UDI-Device Identifier: 00849111001052
• UDI-Public: 00849111001052
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/07/2025

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: 8700-0740-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2011
• 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