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

Device Problems Fumes or Vapors (2529); Ventilation Problem in Device Environment (3027)

Patient Problems Headache (1880); Chemical Exposure (2570)

Event Date 11/30/2017

Event Type  Injury  

Manufacturer Narrative

The facility reported operators of their advantage plus automated endoscope reprocessors were experiencing exposure symptoms (headaches, coughing) from the fumes in their reprocessing room.They requested their machines to be evaluated by medivators.A medivators field service engineer visited the facility and evaluated the aers and surrounding environment.It was noted that the ventilation system connected to the back of the aer and to a cover above the drain is at 10 cfm and medivators requires 25 cfm per the aer site requirements.Also, the furnace had 2 return vents in the room that the facility noted should not be there.The facility's safety department was conducting further testing to determine all air flow problems with the room.No information was made available regarding test results.Medivators fse confirmed that both aers performed within specification and reported no noticeable odors while running cycles.There were no reports of operators seeking additional medical attention.This complaint will continue being monitored within medivators complaint handling system.

Event Description

A facility reported operators were experiencing exposure symptoms to fumes from their advantage plus automated endoscope reprocessors.The facility did not have proper ventilation systems in the room and their safety department is conducting further testing to determine all air flow problems with the reprocessing room.

• 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: 7129809
• MDR Text Key: 95259501
• Report Number: 2150060-2017-00054
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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