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

Device Problem Inadequate Filtration Process (2308)

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

Event Date 11/03/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Medivators field service engineer reported that while onsite for a service call, it was discovered that the.1 micron water pre-filter was bypassed in the water filtration assembly to the advantage plus aer.The facility had modifed the filtration system by hooking the waterline to a separate valve thus bypassing the.1 micron filter.It was reported this was done so the machine could be used while waiting for repair.Improper water pre-filtration could potentially lead to patient infection.Medivators informed the facility the importance of the pre-filtration system and corrected the issue.To date, there have been no reported patient illness or injury.This complaint will continue to be monitored within the medivators complaint handling system.

Event Description

It was reported that the facility had modified their advantage plus aer water pre-filter assembly to bypass the.1 micron water filter.Improper water pre-filtration could potentially lead to patient infection.

• 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: 6143104
• MDR Text Key: 61400825
• Report Number: 2150060-2016-00049
• 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,user f
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 12/02/2016

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2010
• 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