MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON RCI NON-REBREATHER OXYGEN MASK

Catalog Number 1059

Device Problems Thermal Decomposition of Device (1071); Energy Output To Patient Tissue Incorrect (1209); Fire (1245)

Patient Problems Burn(s) (1757); Burn, Thermal (2530)

Event Date 12/06/2013

Event Type  Death  

Event Description

Previously reported as voluntary report (b)(4).Received notice one week ago from an attorney of intent to sue and accompany death certificate.Re-reporting as a mandatory report.Cause of death chf complicated by thermal injuries.Pt first had a removal of temporary pacemaker leads and removal of temporary dialysis cath on the left side.An hour after, the pt was prepped on the left side for placement of a permanent pacemaker.Chloraprep 10.5 ml used on the right side, chloraprep 26 ml used on the left side.After prepping with chloraprep, scrub tech laid surgical towels on the shoulder and went to scrub and get lead apron.At 10-15 minutes later, tech continued with the rest of the sterile field and layout of 3m ioban 2 surgical drape.Placed pacemaker drape and towels.Nurse set up oxygen supply at 15lmp non-rebreather with bag towards the head instead of the feet to clear space for sterile field for procedure.Applied esu return pad to right thigh and connected it to the esu generator.Esu set to 35 watts in cut and coag modes.Esu pencil connected and placed in holster in the surgical field.Esu generator set for use in monopolar mode.After physician scrubbed and gowned, surgical curtain hung over the holder.Physician injected about 20cc of lidocaine cocktail and made three incisions.Picked up the esu pencil to control some bleeders.Activated the pencil by pressing the button in the pencil's handle.Saw a spark flash from the pencil's tip toward the sterile field and up the pt's chin area.Within a second, a flash fire occurred through the surgical towels and the 3m ioban 2 surgical drape, flames shot out of the mask's tubing and burst the facemask bag.Fire noted around the pt's facemask and hair.Set up of burning surgical drape removed and stomped out while the nurse turned the oxygen source off.Fire took 10-15 seconds to extinguish.Fire resulted in thermal burns to face and neck.Pt intubated to protect airway and transferred to a burn center.Changed from a voluntary report to mandatory after further details received.

• Brand Name: HUDSON RCI NON-REBREATHER OXYGEN MASK
• Type of Device: OXYGEN MASK
• Manufacturer (Section D): TELEFLEX MEDICAL; p.o. box 12600; research triangle park NC 27709
• MDR Report Key: 3660780
• MDR Text Key: 18812905
• Report Number: 3660780
• Device Sequence Number: 2
• Product Code: BTM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/21/2014
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1059
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2013
• Distributor Facility Aware Date: 12/06/2013
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 102