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 Patient Involvement (2645)
Date of Event	07/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During preventive maintenance on 03 jul 2020, the autopulse platform (sn (b)(4)) failed during functional testing due to fault 16 (timeout moving to take-up position) error message.The root cause for the reported complaint was due to the corrosion on the brake housing area of the drive train motor.This type of corrosive damage is indicative of infrequent daily checks.Based on the archive review, the platform has not been powered on for more than 6 months and the routine shift check of the platform was not performed daily in which likely caused the brake gap to be seized.The autopulse platform was manufactured in 28 april 2011, and is 9 years old, well beyond its expected service life of 5 years.No preventive maintenance was performed since 2011.During visual inspection, the top cover was cracked.The root cause were likely attributed to mishandling such as a drop.In addition, the platform was observed with the drive shaft exhibiting binding and resistance due to a sticky clutch plate.The root cause was due to wear and tear.Corroded and damaged cable connection from the drive train was observed during internal visual inspection of the platform.The drive train needs to be replaced.Probable root cause was due to mishandling.The autopulse platform failed initial functional testing due to fault 16 error message.While powering on the unit, there was no brake activation.It was noticed that the drive train motor had corrosion at the brake housing area.The brake assembly was seized from corrosion and contributed to the cause of fault 16 and prevent the platform to perform compression.In addition, the platform was further tested including the load cell characterization check which identified defective load cells.The cracked cover and defective load cell were likely attributed to mishandling such as a drop.Waiting for customer's approval for service.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial (b)(4).
Event or Problem Description
During preventive maintenance 03 jul 2020, the autopulse platform (sn (b)(4)) failed during functional testing due to fault 16 (timeout moving to take-up position) 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
• MDR Report Key: 10336493
• Report Number: 3010617000-2020-00729
• Device Sequence Number: 17015363
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2020

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: 06/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1