MAUDE Adverse Event Report: MEDIVATORS ADVANTAGE PLUS; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

Medivators field service engineer discovered while repairing their aer unit that the facility had made multiple modifications and adjustments to the internal system such that the device is out of specification.This includes filter housing and hookup connector modifications.Upon further inspection of the unit and extent of the repairs needed, it was reported that the facility was not doing the necessary maintenance in accordance with the ifu.In the fse report, it stated that multiple machine components were broken, leaking, or even missing.This could potentially lead to improper reprocessing of endoscopes, thus potential for patient harm.This facility does not have a service agreement with medivators, so records indicate that medivators field personnel has not visited this facility since installation.No patient illness or injury has been reported to medivators.This complaint will continue to be maintained within medivators complaint handling system.

Event Description

Medivators field service engineer discovered while repairing their aer unit that the facility had made multiple modifications and adjustments to the internal system such that the device is out of specification.This includes filter housing and hookup connector modifications.This could potentially lead to improper reprocessing of endoscopes, thus potential for patient harm.

• Brand Name: ADVANTAGE PLUS
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: megan dickey ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533327
• MDR Report Key: 6175508
• MDR Text Key: 62536582
• Report Number: 2150060-2016-00052
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: 00677964044755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1