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	12/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported a complaint that "the autopulse platform (sn (b)(4) displayed fault 16 (timeout moving to take-up position)," which was confirmed during the functional testing and archive data review.The root cause of fault 16 was failed drivetrain motor (slipped bushing).When the bushing slips, the drivetrain motor will seize and be unable to rotate, likely due to user maintenance.The storage condition of the autopulse platform is unknown.A review of the autopulse platform archive revealed that daily checks were not performed regularly.Daily device checks are required per the user manual to help prevent the brake from seizing.Also, storing the autopulse in a low-humidity location could help prevent the brake from seizing.Upon visual inspection, unrelated to the reported complaint, noted a cut head restraint from the top cover of the autopulse platform, likely attributed to user mishandling.The patient head restraint wire could have been cut to free the patient from the platform or the user could have been lifting the platform by holding the head restraints.Missing or cut head restraints do not render the autopulse platform non-functional.The top cover needs to be replaced to address the observed physical damage.The archive data review indicated multiple fault 16, thus, confirming the customer's reported complaint.The autopulse platform failed initial functional testing due to fault 16 displayed upon powering on, thus, confirming the reported complaint.The autopulse platform did not achieve the target depth for take-up within the specified time (~5 secs) due to the failed drivetrain motor (slipped bushing).When the bushing slips, the drivetrain motor will seize and be unable to rotate.The drivetrain motor needs to be replaced to remedy the complaint.Zoll is awaiting customer approval for service repair.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)(4).
Event or Problem Description
During shift check, the autopulse platform (sn (b)(4) displayed fault 16 (timeout moving to take-up position) when the start/continue button was pressed.The customer tried to restart the platform and use a different lifeband, but the issue persisted.The original lifeband performed as intended when tested on a different autopulse platform.No patient involvement.

• 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: 16159315
• Report Number: 3010617000-2023-00031
• Device Sequence Number: 15320931
• Product Code: DRM
• UDI-Device Identifier: 00849111002530
• UDI-Public: 00849111002530
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2023

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: 8700-0740-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2019
• 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