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

Device Problem Off-Label Use (1494)

Patient Problems Electric Shock (2554); No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2018

Event Type  Injury  

Manufacturer Narrative

Medivators field service engineer (fse) reported during a service visit for a facility's dsd-201 automated endoscope re-processor (aer), that the aer was modified by adding a switch to shut off the compressor.This modification is not part of the design specifications for the aer, thus the facility is using the device off-label which could present potential user harm.It was reported that the third party managing service company added a switch for the compressor after not being able to find a suspected air leak.The switch allows operators to shut off the compressor and keep it from burning out.Medivators fse fixed the air leak during the service call and did not notice any other visible modifications to the aer.Medivators technical specialist manager reported concerns that the type of switch used is not appropriate for the application of this device.If operators make contact with wet, gloved hands, there is potential to receive an electrical shock.There have been no reports of user harm.This aer is normally serviced and maintained by a third party service company, medservice repair, inc.It is the facility's responsibility to ensure the machine is properly serviced and operating according to medivators specifications.This complaint will continue being monitored in medivators complaint handling system.

Event Description

Medivators field service engineer reported during a service visit for a facility's dsd-201 automated endoscope re-processor, that the aer was modified by adding a switch to shut off the compressor.This modification is not part of the design specifications for the aer, thus the facility is using the device off-label which could present potential user harm.

• Brand Name: 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: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 8180582
• MDR Text Key: 130888153
• Report Number: 2150060-2018-00081
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2004
• 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
• Patient Outcome(s): Other