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

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

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

Event Date 11/16/2018

Event Type  Injury  

Manufacturer Narrative

Medivators field service engineer (fse) reported the facility had their dsd 201 automated endoscope preprocessors (aers).Temperature not set in accordance with the high level disinfectant labeling requirements.There is potential that endoscopes are not reprocessed properly in the aers.The facility uses metricide opa high level disinfectant in their aer which requires a 5-minute contact time at 25°c.The facility's aers was set at 10°c.The facility staff were informed and the medivators fse corrected the basin temperature.The fse tested the machines and they ran within specification with no issues.Per the medivators aers user manual, users are required to verify correct parameter settings that are appropriate for the type of hld utilized.After several attempts at contacting the facility, no information was provided to medivators regarding how many endoscopes were reprocessed at the wrong temperature.There have been no reports of patient harm.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

Medivators field service engineer (fse) reported the facility had their dsd 201 automated endoscope preprocessors (aers).Temperature not set in accordance with the high level disinfectant labeling requirements.There is potential that endoscopes are not reprocessed properly in the aers.

• Brand Name: DSD-201
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer Contact: lauren johnson ; 14605 28th ave n; plymouth, MN 55447 ; 7635533349
• MDR Report Key: 8161811
• MDR Text Key: 130263554
• Report Number: 2150060-2018-00073
• Device Sequence Number: 1
• Product Code: FEB
• 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: health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• 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?: Yes
• Date Manufacturer Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2003
• 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