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

Device Problems Fire (1245); Fluid/Blood Leak (1250); Melted (1385)

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

Event Date 04/15/2014

Event Type  No Answer Provided  

Event Description

Fluid leaked onto the back of medivators advantage plus aer, an electrical component reportedly flamed up and melted.

Manufacturer Narrative

The facility was doing an endo procedure and smelt burning.It was reported that the advantage plus aer unit was turned off when the biomed department checked it out.Fluid had dripped on to an electrical component and had actually flamed up and melted a part on the side of the machine.Medivators advantage plus replacement parts were immediately sent out for repair.A field service technician was sent to investigate the cause of this incident.According to the report, it was not apparent what exactly happened.The check valve on the right side leaked onto the valve and it shorted out.One of three things caused this: the check valves were not replaced at the last pm and became brittle and leaked or the hose clamp was not tight enough on the hose and it leaked or lastly, the hose clamp was over tightened and it broke causing the leak.The advantage plus machine was repaired and it is operating according to specifications.The underlying cause is currently under investigation by medivators quality department.There were no reports of patient injury or illness as a result of this incident.This complaint will continue to be monitored within medivators complaint system.If additional information regarding the returned component becomes available, medivators will review upon receipt.

• Brand Name: MEDIVATORS 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 ; 7635533300
• MDR Report Key: 3802277
• MDR Text Key: 20265798
• Report Number: 2150060-2014-00014
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/05/2014

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: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/15/2014
• Initial Date FDA Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2009
• 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