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
Event or Problem Description
During shift check, the autopulse platform sn (b)(6), displayed a fault 16 (timeout moving to take-up position) message upon powering on.The customer tried to clear the fault code by removing and resetting the lifeband, but the fault code persisted.No patient involvement.
Additional Manufacturer Narrative
Zoll has not received the autopulse platform for investigation.A follow-up report will be submitted if and when the product is returned, and the investigation has been completed.
Additional Manufacturer Narrative
The customer's complaint that the autopulse platform (sn (b)(6) displayed a fault 16 (timeout moving to take-up position) message was confirmed during the functional testing and the archive data review.The root cause of the reported complaint was a narrow brake gap (out of specification).The archive data indicated fault 16, confirming the reported complaint.The autopulse platform failed the functional testing due to fault 16 displayed upon powering up, confirming the reported complaint.The brake gap inspection revealed a narrow, out of specification brake gap and was adjusted within the specification to address the reported complaint.Following service, the autopulse platform passed the run-in and final tests without fault or error.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).

• 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 ; 4084192347
• MDR Report Key: 20409853
• Report Number: 3010617000-2024-00818
• Device Sequence Number: 15433909
• Product Code: DRM
• UDI-Device Identifier: 00849111001090
• UDI-Public: 00849111001090
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 12/31/2024

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: 8700-0740-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• 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