MAUDE Adverse Event Report: MEDIVATORS INC. ADVANTAGE PLUS; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problems Circuit Failure (1089); Fumes or Vapors (2529)

Patient Problems Dyspnea (1816); Itching Sensation (1943); Skin Irritation (2076); Chemical Exposure (2570)

Event Date 03/28/2019

Event Type  Injury  

Manufacturer Narrative

A facility reported that two staff members experienced chemical exposure symptoms from rapicide pa high level disinfectant (hld) fumes during a reprocessing cycle using their advantage plus automated endoscope reprocessor (aer).The facility reported the staff exposure to the hld fumes occurred when their aer issued a communication error during the disinfect phase of a reprocessing cycle causing the cycle to stop when the basins were filled with diluted hld use-solution.The facility then sealed off the reprocessing room and a medivators field service engineer (fse) was dispatched to repair the device.Medivators fse determined the communication error was due to a failed circuit board within the aer.Medivators fse replaced the circuit board which allowed the drain valves to activate and empty the aer basins.The aer was returned to service after confirming it was operating according to specification.Medivators regulatory followed up with the facility for further information regarding the staff who experienced chemical exposure symptoms to the hld fumes.The facility reported the two affected staff members sought medical attention for itchy skin and trouble breathing but that symptoms improved within 24 hours and they are doing fine.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

A facility reported that two staff members experienced chemical exposure symptoms from rapicide pa high level disinfectant fumes during a reprocessing cycle using their advantage plus automated endoscope reprocessor.

• Brand Name: ADVANTAGE PLUS
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: hannah shrader ; 14605 28th ave n; minneapolis, MN 55447 ; 7635596863
• MDR Report Key: 8551998
• MDR Text Key: 143244211
• Report Number: 2150060-2019-00035
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: 00677964044755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2011
• 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