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

Device Problem Fumes or Vapors (2529)

Patient Problems Burning Sensation (2146); Chemical Exposure (2570)

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

The facility reported a nurse was exposed to fumes of rapicide pa high level disinfectant in-use solution while operating their advantage plus automated endoscope reprocessor.The nurse reported inhaling vapor from the hld use-solution while reprocessing a tee probe.She reported to begin coughing and felt a burning sensation in her throat and lungs.Medivators regulatory affairs followed up with the nurse and she reported she did not seek medical attention.She reported she is currently doing fine.Rapicide pa labeling and safety data sheet (sds) instruct users to wear proper protective equipment (ppe) including face protection and warns them to avoid inhaling mists.Facilities are required to have proper ventilation with a minimum of 10 air changes per hour in the room to minimize staff exposure to chemical vapors.The facility is ensuring all employees are wearing appropriate ppe when working with rapicide pa and the aer.This complaint will continue being monitored in medivators complaint system.

Event Description

A facility reported an employee was exposed to fumes of rapicide pa high level disinfectant in-use solution while operating their advantage plus automated endoscope reprocessor.The exposed employee reported experiencing chemical exposure symptoms.

• Brand Name: ADVANTAGE PLUS
• 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: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 7400876
• MDR Text Key: 104530190
• Report Number: 2150060-2018-00027
• 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: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2010
• 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