MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number	MODEL 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	01/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the autopulse platform sn (b)(6) for investigation.A follow-up report will be submitted if and when the product is returned, and the investigation has been completed.
Event or Problem Description
During shift check, the autopulse platform sn (b)(6) displayed a "system error, out of service, revert to manual cpr" message upon powering on.No patient involvement.
Additional Manufacturer Narrative
The customer's complaint of "the autopulse platform (sn (b)(6)) displayed "system error, out of service, revert to manual cpr" was confirmed during archive data review and functional testing.The root cause of the system error was determined to be the drivetrain motor brake gap being wide and out of specification.As a result, the autopulse stopped functioning due to a system error, as designed.The brake gap issue is most likely attributed to wear and tear.The autopulse platform was manufactured in 2016 and is over seven years old.Upon visual inspection, unrelated to the reported complaint, a hole on the load plate cover was observed that affected the watertight seal, likely attributed to user mishandling.The load plate cover was replaced to address the observed physical damage.A review of the archive data showed a system error 139 (unable to hold compression position) around the reported event date, confirming the reported complaint.The autopulse platform failed initial functional testing due to "system error, out of service, revert to manual cpr" upon powering up the device, confirming the reported complaint.The brake gap was cleaned and adjusted within the specification to address the system error.Also, unrelated to the reported complaint, the backlight of the lcd flickers briefly upon powering on and is dark afterward.The root cause of the lcd issue was a malfunctioning processor board, likely attributed to the device's aging.The processor board was replaced to address the observed lcd issue.Following service, the brake gap inspection was performed, and it was verified that the brake gap was within the specification.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).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• 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: 18699772
• Report Number: 3010617000-2024-00113
• Device Sequence Number: 7352473
• 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): 03/15/2024

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: MODEL 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: 01/18/2024
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2016
• 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