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

Model Number DSD-201

Device Problems Use of Device Problem (1670); No Flow (2991)

Patient Problems Exposure to Body Fluids (1745); Chemical Exposure (2570)

Event Date 12/10/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The dsd-201 automated endoscope reprocessor (aer) displayed a no air flow error message when the operator tried to abort a cycle.The operator opened the aer lid to check the hookup to endoscope connections.One of the hookup tubes was pulled on and resulted in fluid blowing in the operator's face, therefore potential disinfectant and/or contaminated fluids exposure.The operator washed her face and hands thoroughly and did not experience illness or injury.The dsd-201 instructions for use state to never open the reprocessor lid or remove the floating basin lid during operation.The operator's current condition is fine.To date, there have been no further problems with the air flow.This complaint will continue to be monitored in the mediator's complaint handling system.

Event Description

The dsd-201 automated endoscope reprocessor (aer) displayed a no air flow error message when the operator tried to abort a cycle.The operator opened the aer lid to check the hookup to endoscope connections.One of the hookup tubes was pulled on and resulted in fluid blowing in the operator's face, therefore potential disinfectant and/or contaminated fluids exposure.

• Brand Name: MEDIVATORS 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: kristin bergeson ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 5354648
• MDR Text Key: 35463694
• Report Number: 2150060-2016-00001
• 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: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DSD-201
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2012
• 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
• Treatment: RAPICIDE HIGH-LEVEL DISINFECTANT AND STERILANT