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	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During preventative maintenance (pm), the autopulse platform (sn 41436) failed functional testing and displayed fault code 21 (drive shaft turns in wrong direction) upon powering up.No patient involvement.
Additional Manufacturer Narrative
During preventative maintenance (pm), the autopulse platform (sn 41436) failed functional testing and displayed fault code 21 (drive shaft turns in wrong direction) upon powering up.The root cause of fault code 21 was the malfunctioning drivetrain motor, likely due to the age of the device.The autopulse platform was manufactured in november 2015 and is over 8 years old, well beyond its expected service life of 5 years.The drivetrain motor assembly needs to be replaced to remedy the fault.Visual inspection of the autopulse platform showed no physical damage.A review of the archive data showed multiple fault code 08 (motor controller malfunction) and a user advisory (ua) 17 (max motor on-time exceeded during active operation).The root cause of the intermittent occurrences of fault code 08 was determined to be the malfunctioning drivetrain motor.Upon further inspection, the drivetrain motor brake gap was found to be too narrow (out of the specification), triggering the ua17 advisory.Replacement of the drivetrain motor assembly will address fault 08 and ua17, which were noted in the archive data.Zoll is awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaints were reported for the autopulse platform with serial number 41436.

• 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: 18576515
• Report Number: 3010617000-2024-00072
• Device Sequence Number: 7708716
• 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): 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): 01/24/2024

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: MODEL 100
• Device Catalogue Number: 8700-0740-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2015
• 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