• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDIVATORS DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR Back to Search Results
Model Number DSD-201
Device Problems Bacterial Filter (417); Filter (816); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/03/2018
Event Type  Injury  
Manufacturer Narrative

A medivators field service engineer was at a facility servicing a dsd-201 automated endoscope reprocessor and reported the facility was using the incorrect 0. 2 micron water filter with their unit. The water filter being used is not intended to be used with the filter housing unit it was in and was found to be unattached to the filter port. There is potential that microbial contamination was introduced to the aer, thus there is potential for patient adverse effects. It is unknown how long the facility had been using the incorrect 0. 2 micron water filter with their aer. The facility confirmed they had the correct 0. 45 micron pre-filter and a sediment pre-filter. They have since installed the correct 0. 2 micron filter in their aer. The facility is looking into getting a service contract with medivators. There have been no reports of patient harm related to potential bacterial contamination from endoscopes reprocessed in this aer. This complaint will continue being monitored in medivators complaint handling system. Facility information: (b)(6).

 
Event Description

A medivators field service engineer was at a facility servicing a dsd-201 automated endoscope reprocessor and reported the facility was using the incorrect water filter with their unit. There is potential for microbial contamination to be introduced while reprocessing endoscopes, thus there is potential for patient adverse effects.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7390564
MDR Text Key104132779
Report Number2150060-2018-00024
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 MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial
Report Date 04/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberDSD-201
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/03/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/25/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/02/2018 Patient Sequence Number: 1
-
-