MAUDE Adverse Event Report: MEDIVATORS MEDIVATORS RAPICIDE PA; PERACETIC ACID

Catalog Number ML02-0117

Device Problem Device Emits Odor (1425)

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

Event Date 12/11/2013

Event Type  No Answer Provided  

Event Description

Inhalation exposure to rapicide pa fumes.Operator went the er with symptoms of burning sensation in the nose, throat and lungs.

Manufacturer Narrative

Limited information has been provided to the manufacturer.Medivators advantage plus automated endoscope preprocessor's reservoirs were emptied via remote "log-in" by a medivators technical service representative.While logged in, he emptied both a and b dosing reservoirs and rinsed basin with water to flush out chemistry.After this flush, the operator was asked to put a scope in the unit in order to test the machine.We she opened the lid is was reported that a "tremendous amount of fumes" came out of the machine.The operator's inhalation exposure was treated at the er with symptoms of burning sensation in her nose, throat and lungs.She was prescribed a steroid to help with the problem.Tech service representative that took this call informed them that "there is no lasting affects of this type of exposure, but should follow physicians advice." it is unknown if the operator was wearing proper ppe while operating the machine as recommended by the manufacturer.Upon receipt of additional information, medivators will review and determine if further action is needed.

• Brand Name: MEDIVATORS RAPICIDE PA
• Type of Device: PERACETIC ACID
• 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: 3551021
• MDR Text Key: 4102865
• Report Number: 2150060-2014-00002
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: ML02-0117
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/12/2013
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/12/2013
• Initial Date FDA Received: 01/03/2014
• 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
• Patient Outcome(s): Hospitalization