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

Model Number	100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During preventative maintenance (pm) performed at zoll, the autopulse platform (sn (b)(6)) passed the initial functional test without fault or error, but it failed the load cell characterization test.The root cause of the noted issue was the malfunctioning load cell #2, likely attributed to failed component(s) or mishandling, such as a drop.The failed load cell was replaced to remedy the fault.Unrelated to the noted failure, the drivetrain motor brake gap was found to be out of the specification (too narrow).This did not render the platform non-functional.The brake gap was adjusted within the specification to resolve the issue.During further inspection, it was noticed that the screws on the drivetrain motor brake were loose, which contributed to intermittent occurrences of several user advisory (ua) 17 (max motor on-time exceeded during active operation) that were recorded in the archive data.The screws were tightened to specification during the preventative maintenance service actions.Visual inspection of the autopulse platform did not show physical damage.Following service, another brake gap inspection was performed and verified the brake gap was within the specification.Another load cell characterization test was performed and confirmed that both cell modules were functioning within the specification.The autopulse platform was subjected to a run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without fault or error.Historical complaints were reviewed for service information related to the reported complaint, and one similar complaint was found for the autopulse platform with serial number (b)(6).Ccr 45095 was reported for ua07 (failed load cell characterization test) on 10 may 2019, and load cell #2 was replaced to remedy the fault.
Event or Problem Description
During preventative maintenance (pm), the autopulse platform (sn (b)(6)) failed the load cell characterization test.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: 18297750
• Report Number: 3010617000-2023-01058
• Device Sequence Number: 17971032
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care 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: 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: 11/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2015
• 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