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

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 10/25/2017

Event Type  Injury  

Manufacturer Narrative

A medivators field service engineer was dispatched for preventative maintenance (pm) servicing on a facility's dsd-201 automated endoscope reprocessor.While the fse was at the facility, he discovered that all three of their machines had major leaks along with cracked basins.The fse informed the facility that they should not be using these machines with damaged basins as any irregularities, cracks, or uneven surfaces could harbor bacteria/organisms which then could be introduced to the endoscope.There is potential for patient harm.This facility does not have a service contract with medivators so it is unknown how long these units have been damaged and how they became damaged as their units were not being serviced or repaired by medivators.It is also unknown if the facility is still using these units.It was reported that there was poor maintenance and very low overall hygiene of the facility.There has been no reported patient harm.This complaint will continue being monitored in medivators complaint handling system.

Event Description

A facility requested decontamination and preventative maintenance (pm) services for their dsd-201 automated endoscope reprocessor.A medivators field service engineer discovered that all three of the facility's machines had major leaks along with cracked basins.Aers with damaged basins present a risk of bacteria and organisms and could potentially lead to patient harm.It was reported that the machines were in bad condition and were not appropriately maintained.It was recommended by medivators these machines be taken out of service.

• 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: 7053675
• MDR Text Key: 92794092
• Report Number: 2150060-2017-00050
• 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: Medical Equipment Company Technician/Representative
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/22/2017

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2010
• 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
• Patient Outcome(s): Other