MAUDE Adverse Event Report: ORIDION MEDICAL NELLCOR; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	N85
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Death (1802)
Date of Event	02/11/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Device issue was not related to the patient death.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device was caught on fire which allegedly caused by the defibrillator.It was reported that the device was not powered on and was not connected to the patient.The device was burned/melted due to fire from electrical energy arc from defibrillator pad and high flow oxygen from nasal cannula in patient's bed.The customer reported that the patient had burns to head, neck, face, ears and shoulders due to the fire and died due to cardiac arrest.The cause of death was not related to device.

• Brand Name: NELLCOR
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• MDR Report Key: 8416857
• Report Number: 8044004-2019-00004
• Device Sequence Number: 1955038
• Product Code: CCK
• UDI-Device Identifier: 10884521172043
• UDI-Public: 10884521172043
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150844
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N85
• Device Catalogue Number: N85
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death