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

Model Number N85

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 02/11/2019

Event Type  Death  

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 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
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• Manufacturer (Section G): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 8416857
• MDR Text Key: 138672088
• Report Number: 8044004-2019-00004
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10884521172043
• UDI-Public: 10884521172043
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150844
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: N85
• Device Catalogue Number: N85
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/13/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death