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	01/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event on the autopulse platform (sn (b)(4)) displaying user advisory (ua) 17 (motor on for too long during active operation) error message was confirmed during functional testing and archive data review.Root cause is due to a defective drivetrain motor as result of normal wear and tear.Upon visual inspection, the platform was found to have a hole on the load plate cover and the drive shaft was exhibiting binding and resistance.These observations are not related to the reported event.During functional testing on run-in test the platform repeatedly stopped compression and displayed user advisory (ua) 17 (motor on for too long during active operation) error message.The ua 17 error message was due to a defective drivetrain motor.The archive data was reviewed and contained multiple ua 17 error messages on the reported event date.Upon replacement of the front enclosure, battery latch, drivetrain and load cell, the platform was functionally tested and operated as intended.The platform passed all testing specifications with no further issue observed.The autopulse platform is a reusable device and was manufactured on 28 apr 2011.It has exceeded its expected service life of 5 years.The platform is 7 years old and has not seen regular preventive maintenance.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse serial number (b)(4).
Event or Problem Description
During testing on a mannequin, the autopulse platform (sn (b)(4)) displayed a user advisory (ua) 17 (motor on for too long during active operation) 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: 8287632
• Report Number: 3010617000-2019-00045
• Device Sequence Number: 2081733
• Product Code: DRM
• UDI-Device Identifier: 00849111000574
• UDI-Public: 00849111000574
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 01/29/2019

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: 8700-0730-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1