FDA Adverse Event Death Summary report: N

EVERFLO OXYGEN CONCENTRATOR

MDR report key: 3688197 · Received March 13, 2014

Report

Report Number
MW5034984
Event Type
Death
Date Received
March 13, 2014
Date of Event
February 9, 2014
Report Date
March 6, 2014
Manufacturer
PHILIPS HEALTHCARE
Product Code
CAW
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ON WEDNESDAY, (B)(6) 2014, WE RECEIVED A CALL FROM (B)(6), THE SPOUSE OF THE CLIENT. (B)(6) STATED THAT HE WANTED TO SCHEDULE A PICKUP OF THE OXYGEN EQUIPMENT THAT HAD BEEN BEING USED BY THE CLIENT. WHEN ASKED FOR THE REASON OF THE PICKUP, (B)(6) STATED THAT THE CLIENT HAD PASSED AWAY. UPON FURTHER DISCUSSION, (B)(6) STATED TO OUR CSR THAT THE CLIENT HAD BURNED HERSELF WHILE USING THE OXYGEN, AND SUBSEQUENTLY PASSED AWAY. OUR CSR IMMEDIATELY INFORMED ME OF THE SITUATION, AND I SCHEDULED TO DO THE PICKUP MYSELF ON (B)(6) 2014. I ARRIVED AT THE CLIENT'S HOME ON FRIDAY, (B)(6) 2014, AT APPROXIMATELY 12:46PM. I COMPLETED THE PICKUP OF THE OXYGEN EQUIPMENT AT APPROXIMATELY 1:09PM. DURING MY TIME THERE, I INTERVIEWED (B)(6) AND RECEIVED THE FOLLOWING STATEMENT(S): ON SUNDAY, (B)(6) 2014, WHILE USING HER OXYGEN, THE CLIENT BENT DOWN TO LIGHT A CIGARETTE WITH A CIGARETTE LIGHTER. HER HAIR FELL INTO THE FLAME AND CAUGHT FIRE. IN AN ATTEMPT TO EXTINGUISH THE FLAME, THE CLIENT SWEPT HER HAND ACROSS HER FACE AND HEAD, KNOCKING THE CANNULA OUT OF HER NOSE AT WHICH POINT A LARGE FLASH OCCURRED, BURNING THE CLIENT'S FACE, EAR, AND NOSE. SHE WAS NOT IN PAIN AND ONLY SUFFERED REDNESS ON THE BURNED AREAS, SO IT WAS DECIDED, BY BOTH THE CLIENT AND CUTLER, THAT THERE WAS NO NEED FOR MEDICAL ATTENTION. ON WEDNESDAY, (B)(6) 2014, THE CLIENT WOKE UP COMPLAINING OF PAIN AROUND THE AFFECTED AREA. AN APPOINTMENT WAS MADE FOR THE CLIENT THAT SAME DAY AT THE (B)(6) WHERE SHE WAS SEEN BY FAMILY NURSE PRACTITIONER, (B)(6), FNP. THE CLIENT WAS PRESCRIBED PAIN MEDICATION AND SENT HOME WITH A FOLLOW-UP APPOINTMENT FOR THE FOLLOWING DAY, AT WHICH TIME THEY WERE GOING TO "CLEAN OUT HER NOSE" (REMOVE DEAD/SLOUGHED SKIN FROM HER NASAL PASSAGES). ON THURSDAY, (B)(6) 2014, (B)(6) ATTEMPTED TO WAKE THE CLIENT SO SHE COULD MAKE HER MEDICAL APPOINTMENT, BUT HE WAS UNABLE TO DO SO. (B)(6) STATED THAT THE CLIENT WAS BREATHING, BUT WAS TOTALLY UNRESPONSIVE. (B)(6) CALLED (B)(6), FNP AT THE MEDICAL CENTER TO REPORT THE GOING ONS. (B)(6) MADE A HOUSE-CALL TO THE HOME AND FOUND THE CLIENT STILL UNRESPONSIVE. (B)(6) TESTED THE CLIENT'S VITALS AND ACCORDING TO CUTLER, THE CLIENT HAD A PULSE AND NORMAL BLOOD PRESSURE. LUKE DETERMINED THAT 911 SHOULD BE CALLED, AT WHICH POINT IT WAS. EMS ARRIVED, LOADED THE CLIENT INTO AN AMBULANCE, AND HEADED TOWARDS (B)(6) HOSPITAL. APPROXIMATELY HALFWAY TO THE HOSPITAL, THE CLIENT WENT INTO CARDIAC ARREST. ATTEMPTS TO REVIVE HER WERE UNSUCCESSFUL AND SHE WAS PRONOUNCED DECEASED. ON THURSDAY, (B)(6) 2014, I BEGAN FILLING OUT THE FDA 3500A FORM. ON FRIDAY, (B)(6) 2014, I COMPLETED THE FORM AND CONTACTED PHILIPS HEALTHCARE, THE DEVICE MANUFACTURER, BY TELEPHONE TO REPORT THIS EVENT. I SPOKE WITH (B)(4) IN THE PRODUCT SUPPORT DIVISION. (B)(4) STATED THAT SOMEONE FROM THEIR QUALITY CONTROL DEPARTMENT WOULD BE CONTACTING ME. DOSE: 2 LPM CONTINUOUSLY. VIA NASAL CANNULA. THERAPY DATES: (B)(6) 2011 TO (B)(6) 2014. INDICATION: CHRONIC AIRWAY OBSTRUCTION NEC, DIAG. CODE 496. INITIAL REPORTER: (B)(6). REPORTED VIA PHONE (B)(6) 2014 - INTERVIEWED (B)(6) 2014. PHONE #: (B)(6). REPORT# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
151577 EVERFLO OXYGEN CONCENTRATOR CONCENTRATOR CAW PHILIPS HEALTHCARE EVERFLO

Patients

Seq Age Sex Outcome Treatment
1 65 YR Death