MAUDE Adverse Event Report: MEDIVATORS MEDIVATORS DSD-201; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number DSD-201

Device Problems Thermal Decomposition of Device (1071); Electrical /Electronic Property Problem (1198); Smoking (1585); Arcing (2583)

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

Event Date 03/27/2014

Event Type  No Answer Provided  

Event Description

Electrical short in the incoming power module of dsd-201.The power inlet and the power cord arced, burned and created smoke.No injury reported, no need to evacuate.

Manufacturer Narrative

The case states that there was an electrical short in the incoming power module of a medivators dsd-201 automated endoscope reprocessor.The power inlet and the power cord arced, burned and created smoke.Possible cause was fluid on the outside of the machine made contact with plug.Fluid could travel down the power cord into plug if the cord was stretched.Another potential cause was the plug was rather loose causing the connection to over-heat.There is limited evidence as to the actual cause of this incident.Burnt parts and rear outlets are being returned to medivators for further examination and investigation.Medivators fse reported to investigate this machine.He is still in contact with this customer.The dsd-201 machine has been cleaned and repaired according to specifications.There were no injuries, no need to evacuate and no delay in patient treatment reported as a result of this incident.Detailed information on this complaint is documented within medivators complaint system.

• Brand Name: MEDIVATORS DSD-201
• 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: 3770120
• MDR Text Key: 4374612
• Report Number: 2150060-2014-00011
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/24/2014

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: DSD-201
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2012
• 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