MAUDE Adverse Event Report: MEDIVATORS MEDIVATORS RAPICIDE PA; HIGH LEVEL DISINFECTANT

Model Number ML02-0117

Device Problem Fumes or Vapors (2529)

Patient Problems Eye Injury (1845); Headache (1880); Nausea (1970); Burning Sensation (2146)

Event Date 08/27/2014

Event Type  No Answer Provided  

Event Description

The case states that user/handlers of medivators rapicide pa at the facility are experiencing exposure symptoms such as burning throats and eyes, headaches, and nausea from the fumes.

Manufacturer Narrative

The case states that the medivators advantage plus machine operators/scope technicians are experiencing exposure symptoms to the rapicide pa high level disinfectant.These symptoms include burning throats/eyes, headaches, and nausea.Medivators field service engineer was onsite to inspect the advantage plus aers that use rapicide pa.It was reported that these machines were installed roughly 2 weeks ago and replaced custom ultrasonic units running cidex opa.There are no leaks, and both machines are functioning properly.The fse also reported that "there is nothing i experienced during my visit that had me concerned, and i did not notice an overwhelming, overpowering chemical odor that would have me concerned for patients and/or users.This is a new customer with new chemistry and a new reprocessing cycle." it is unknown as to whether or not the user/handlers were wearing the appropriate personal protective equipment as reccomended by the manufacturer.Medivators has no prior complaints of long term affects of rapicide pa exposure.This complaint will continue to be monitored within medivators complaint system.

• Brand Name: MEDIVATORS RAPICIDE PA
• Type of Device: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: megan dickey ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533327
• MDR Report Key: 4110019
• MDR Text Key: 4717524
• Report Number: 2150060-2014-00036
• Device Sequence Number: 1
• Product Code: FEB
• 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,Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/22/2014

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
• Device Model Number: ML02-0117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2014
• Initial Date FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ADVANTAGE PLUS AER