MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; 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	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2021, during preventive maintenance, the autopulse platform ((b)(4)) failed functional testing as the drive train motor was unable to maintain compressions and displayed "system error, out of service, revert to manual cpr" error message.The root cause was due to a defective drive train motor, likely due to wear and tear since the platform was manufactured in 10 june 2014 and is 6 years old, past its expected serviceable life of 5 years.During visual inspection, cracked front enclosure was observed likely due to user mishandling such as a drop.In addition, encoder drive shaft was not rotating smoothly and exhibits binding and resistance.The root cause was due to the sticky driveshaft clutch area, which is usually caused by sharp edges from all 12-hex edges of the armature plate or due to burrs on the surface of the clutch rotor, likely attributed to normal wear and tear.Deburring and filing of the clutch plate will be performed to remedy the problem.The impact of sticky clutch was not severe enough to make the platform non-functional.The archive data review showed the occurrence of system error - user advisory (ua) 132 (internal watchdog timeout), fault 16 (timeout moving to take-up position) and fault 8 (motor controller fault detected) error messages which indicates a defective drive train motor.The drive train motor needs to be replaced to address the system error.Waiting for customer approval for repair.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(4).
Event or Problem Description
On (b)(6) 2021, during preventive maintenance the autopulse platform (sn (b)(4)) failed functional testing as the drive train motor was unable to maintain compressions and displayed "system error, out of service, revert to manual cpr" error message.No patient involvement.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 11605607
• Report Number: 3010617000-2021-00293
• Device Sequence Number: 17060822
• Product Code: DRM
• UDI-Device Identifier: 00849111000536
• UDI-Public: 00849111000536
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2021

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: 8700-0730-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1