MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS IFILL; OXYGEN FILLING SYSTEM

Model Number	535I
Medical Device Problem Code	Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/31/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit was recently returned to devilbiss healthcare and is being evaluated to determine the facts and extend of the event, as well as the root cause.Preliminary examination of the device suggests external variables and actions may have contributed to the event.The unit is undergoing a comprehensive evaluation and analysis; no additional details are available at this time.
Event or Problem Description
The complaint was reported from a long term care facility in france.There is no adverse event or injury associated with the complaint.A nurse was removing/disconnecting a full ifill oxygen cylinder from the ifill oxygen transfill unit, at which time she heard a loud sound and saw a brief flame coming from the oxygen connecting port.The nurse is unsure if the ifill unit was running or had stopped at the time she disconnected cylinder but it noted the ifill unit was plugged into the wall.The nurse stated she heard a loud sound and saw a brief flame, which caused the nurse to drop the cylinder to the floor.Once the cylinder was on the floor the event ended; she reported no other issues with the cylinder or the ifill unit.The cylinder and transfill device were quarantined and the oxygen supplier contacted.The facility acknowledges the routine use of cleaning agent on the ifill cylinder that contains high concentrations of propranolol and ethanol.The cleaning agent is highly flammable and is contraindicated for use with oxygen equipment.There were no injuries or damage related to this event.

• Brand Name: DEVILBISS IFILL
• Common Device Name: OXYGEN FILLING SYSTEM
• Manufacturer (Section D): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• MDR Report Key: 6142736
• Report Number: 2515872-2016-00002
• Device Sequence Number: 18921956
• Product Code: CAW
• UDI-Device Identifier: 00885304000860
• UDI-Public: 00885304000860
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K053240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/04/2016

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?: Yes
• Operator of Device: Nurse
• Device Model Number: 535I
• Device Catalogue Number: 535I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2016
• Initial Report FDA Received Date: 12/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1