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

Model Number DSD-201 120V

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem No Information (3190)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

Medivators field service engineer (fse) reported a facility had their basin temperature set below the minimum requirement for a dsd 201 automated endoscope repocessor (aer).There is potential that endoscopes were not adequately high level disinfected.Medivators fse reported the facility was using cidex opa high level disinfect (hld).The temperature for was set below the minimum requirement and the heater on side a was turned off.The fse adjusted the temperature and turned the side heater on.The fse also found that an air filter on side b was installed backwards and lid cylinders needed urgent replacement.The fse made necessary adjustments and completed test cycles.The aer performed according to specification.The aer was installed in 2003.There is no indication that the aer malfunctioned.Per the medivators dsd-201 user manual, users are required to verify the correct parameter settings for the type of hld being used.The aer was last serviced (b)(6) 2018 by medivators fse and was found to be performing to specification.It is unknown at what point the incorrect temperature settings were made and the number of endoscopes that were reprocessed.There have been no reports of patient harm.This complaint will be monitored in the medivators complaint handling system.

Event Description

Medivators field service engineer (fse) reported a facility had their basin temperature set below the minimum requirement for a dsd 201 automated endoscope repocessor (aer).There is potential that endoscopes were not adequately high level disinfected.

• Brand Name: DSD-201
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; plymouth, mn
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; plymouth, mn
• Manufacturer Contact: lauren johnson ; 9800 59th ave n; plymouth, mn
• MDR Report Key: 9774454
• MDR Text Key: 192739903
• Report Number: 2150060-2020-00008
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DSD-201 120V
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other