MAUDE Adverse Event Report: MEDIVATORS DSD-EDGE; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number 78400-409

Device Problem Melted (1385)

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

Event Date 02/11/2014

Event Type  malfunction  

Event Description

Medivator's dsd edge machine experienced a power inlet meltdown due to non-medivators approved parts installed and repaired by a source other than medivators field service engineers.

Manufacturer Narrative

The facility called for repair of their dsd-edge machine claiming a smell of burnt electrical components.Apparently there was a lot of smoke and the power inlet melted including the gfi (ground fault circuit interruptor) box was damaged and burnt looking.Note: no users or handlers were injured as a result of this incident.After close inspection by medivators field service engineer (fse), there were parts within the machine that had been modified from factory standards.This provided evidence that the machine had been repaired with non-medivators approved parts.The facility had the machine serviced by a source other than medivators technical support personnel.In conclusion, the cause of the meltdown was the side b basin, rear overflow fitting, which is molded into the basin had cracked.The crack allowed the fluid from the basin to drip onto the gfci, or power inlet box and short out.This box is not water tight, since it usually is not a wet location.The cause of this crack is unknown.It is suspected that this crack could have happened during the installation of the improper/ non-medivators approved modifications.It is unlikely an operator could have caused this fitting to crack.The full report of medivators fse can be found in the attached report.

• Brand Name: DSD-EDGE
• 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: 3645882
• MDR Text Key: 4205758
• Report Number: 2150060-2014-00006
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/25/2014

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
• Device Model Number: 78400-409
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/11/2014
• Device Age: 3
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/11/2014
• Initial Date FDA Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2010
• 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