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U.S. Department of Health and Human Services

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

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MEDIVATORS DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR Back to Search Results
Device Problems Bacterial Filter (417); Use of Incorrect Control Settings (1126)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/21/2018
Event Type  Injury  
Manufacturer Narrative

Medivators field service engineer (fse) reported while on site at a facility servicing their dsd-201 automated endoscope reprocessor (aer) that one basin of the aer had the incorrect temperature settings per the rapicide high-level disinfectant being used. There is potential that endoscopes reprocessed in the aer were not adequately high-level disinfected, thus there is potential for patient harm. The facility uses rapicide high level disinfectant in their aer which requires a 5-minute minimum contact time at 35°c. The facility's aer was set to 20°c. While onsite, medivators fse observed a cycle printout showing an endoscope was reprocessed at 27°c. Facility staff were informed of the fse's findings and it was reported that the endoscope reprocessed at 27°c was manually high-level disinfected afterwards. Medivators fse corrected the temperature setting and recommended the facility review their cycle reports to check if other endoscopes were reprocessed at temperatures below the minimum requirement of 35°c. Per the medivators dsd-201 user manual, users are required to verify correct parameter settings are appropriate for the type of hld utilized. No information was provided to medivators regarding how many cycles may have been affected. Medivators fse also reported during his service visit that the facility had installed the water filters in their aer incorrectly. They had placed the 0. 45 micron filter before the 1. 0 micron filter. Facility staff were informed and medivators fse correctly installed new filters for the facility. There have been no reports of patient harm. This complaint will continue being monitored in medivators complaint handling system.

 
Event Description

Medivators field service engineer reported while on site at a facility servicing their dsd-201 automated endoscope reprocessor that one basin of the aer had the incorrect temperature settings per the rapicide high-level disinfectant being used. There is potential that endoscopes reprocessed in the aer were not adequately high-level disinfected, thus there is potential for patient harm.

 
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Brand NameDSD-201
Type of DeviceAUTOMATED 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 Key7894205
MDR Text Key120875592
Report Number2150060-2018-00064
Device Sequence Number1
Product Code FEB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK914145
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 09/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/20/2018 Patient Sequence Number: 1
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