MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE®RESUSCITATION SYSTEM; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	100
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During service at zoll, the autopulse platform (sn 41416) failed functional testing due to a "system error, out of service, revert to manual cpr" message displayed upon powering on.The system error - ua139 (unable to hold compression position) was cleared using apvision3 software during device evaluation performed at zoll.During further testing, the system error did not occur again.Upon further functional testing, the backlight of the lcd was noted to be flickering briefly upon powering on and went dark afterward.The malfunctioning processor board pca assembly was replaced to address the issues.The likely root cause of the malfunctioning processor board was the device's aging.The autopulse platform was manufactured in 2015 and is eight years old, past the expected serviceable life of five years.Upon visual inspection, no physical damage was noted.Upon further testing, the brake gap inspection verified the brake gap was within the specification.During service, the temperature sensor was replaced to address the fault 41 (patient temperature sensor failure) observed during the archive data review.Following service, a load cell characterization test confirmed that both cell modules function within the specification.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 no similar complaint was reported for the autopulse platform with sn (b)(6).
Event or Problem Description
During service at zoll, the autopulse platform (sn 41416) failed functional testing due to a "system error, out of service, revert to manual cpr" message displayed upon powering on.Also, the backlight of the lcd was noted to be flickering briefly upon powering on and went dark afterward.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: 17977241
• Report Number: 3010617000-2023-00909
• Device Sequence Number: 19724927
• Product Code: DRM
• UDI-Device Identifier: 00849111001076
• UDI-Public: 00849111001076
• 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: 8700-0740-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2015
• 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