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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse platform sn (b)(6) failed functional testing due to fault 43 (fan fault detected) during the test run at zoll.The root cause of fault 43 was a malfunctioning fan, likely due to the device's aging.The autopulse platform was manufactured in 2016 and is seven years old, past the expected serviceable life of five years.The fan assembly was replaced to address the observed fault code.Upon visual inspection, a crack on the front enclosure was noted, likely attributed to wear and tear or user mishandling, such as a drop.The front enclosure was replaced to address the observed physical damage.Upon further inspection, the encoder drive shaft does not rotate smoothly and exhibits binding and resistance.The root cause was the sticky driveshaft clutch area, which is usually caused by sharp edges from all 12-hex edges of the armature plate or due to burrs on the clutch rotor's surface, likely attributed to normal wear and tear.The sticky clutch's impact was not severe enough to make the platform non-functional.The clutch plate needs to be deburred to remedy the problem.During functional testing, the brake gap inspection verified the brake gap was narrow and out of specification, likely attributed to the loose brake screws.The screws were tightened, and the brake gap was adjusted within the specification to address the observed problem.In addition, the temperature sensor was replaced to address the intermittent failure.A load cell characterization test confirmed that both cell modules function within the specification.After part replacement, the autopulse platform was tested extensively using multiple batteries and a large resuscitation test fixture (lrtf) with no errors or faults.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).
Event or Problem Description
During service at zoll, the autopulse platform (sn (b)(6)) failed functional testing due to fault 43 (fan fault detected) displayed upon the test run.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: 18141099
• Report Number: 3010617000-2023-00951
• Device Sequence Number: 7998863
• Product Code: DRM
• UDI-Device Identifier: 00849111001076
• UDI-Public: 00849111001076
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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: 8700-0740-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2016
• 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