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

Model Number	MODEL 100
Medical Device Problem Codes	Use of Device Problem (1670); Visual Prompts will not Clear (2281); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During preventive maintenance (pm) performed at zoll, the drivetrain motor of the autopulse platform (s/n (b)(4)) ran with no power and was unusually loud.During further testing, the platform stopped compressions and displayed fault code 16 (timeout moving to take-up position).No patient involvement.
Additional Manufacturer Narrative
During preventative maintenance (pm) performed at zoll, the autopulse platform (s/n (b)(4) powered up and passed the load cell characterization test.However, the platform's drivetrain motor was unusually loud during rotation and ran with no power.As a result, the autopulse platform could not reach the target compression depth within the required time.During further testing, the platform stopped compressions and displayed fault code 16 (timeout moving to take-up position).Troubleshooting the problem determined that the root cause of the noted issues was the defective drivetrain motor.Technical device evaluation revealed that the drivetrain brake gap was too wide, out of the specification, likely attributed to the aging of the device/wear and tear.The autopulse platform was manufactured in december 2015 and is over 6 years old.The platform has exceeded its expected service life of 5 years.The defective drivetrain motor needs to be replaced to remedy the faults.Visual inspection was performed and found no physical damage to the autopulse platform.Zoll is awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for autopulse platform with serial number (b)(4).
Additional Manufacturer Narrative
This supplemental mdr was created to retract the submitted mdr, as the autopulse platform (sn (b)(6)) was a demo device owned by zoll and was not used on a patient.Therefore, this event is a non-complaint.

• 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: 15397846
• Report Number: 3010617000-2022-01628
• Device Sequence Number: 17407571
• 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): 08/03/2023

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: 8700-0740-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 09/11/2022
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2015
• 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