MAUDE Adverse Event Report: ZOLL CIRCULATION 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	11/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During servicing at zoll, the autopulse platform sn (b)(6) failed initial functional testing due to fault 27 (encoder fault).The root cause of fault 27 was a malfunctioning encoder, likely due to the device's aging.The autopulse platform was manufactured in 2012 and is over 11 years old, well past the expected serviceable life of five years.The encoder needs to be replaced to address the observed fault code.Upon visual inspection, no physical damage was observed.The brake gap inspection was performed, and the brake gap was verified to be within the specification.A load cell characterization test confirmed that both cell modules function within the specification.Zoll is awaiting customer approval for service 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).
Event or Problem Description
During servicing at zoll, the autopulse platform sn (b)(6) failed initial functional testing due to fault 27 (encoder fault).No patient involvement.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: AUTOPULSE®RESUSCITATION SYSTEM
• Common Device Name: CARDIAC RESUSCITATOR, LINE-POWERED
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18193359
• Report Number: 3010617000-2023-01022
• Device Sequence Number: 6703531
• Product Code: DRM
• UDI-Device Identifier: 00849111000130
• UDI-Public: 00849111000130
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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: Other
• Device Model Number: 100
• Device Catalogue Number: 8700-0700-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2012
• 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