MAUDE MDR 2009075

MDR report key
2009075
Report number
2009075
Event key
0
Event type
3
Date of event
2011-02-24
Date received
2011-03-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OXYGEN FLOWMETEROXYGEN FLOWMETERPRECISION MEDICAL INC.CAX2MFA1001** N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-03-010

Event Narratives#

D

Patient 1

NURSE NOTICED SOMETHING WAS NOT RIGHT WITH THE FLOW METER AND ASKED THE CHARGE NURSE TO CHECK THE FLOW METER. THE PATIENT WAS ON AN OXYGEN FACE MASK CONNECTED TO THE FLOW METER INVOLVED IN THE INCIDENT. AS THE CHARGE NURSE ENTERED THE ROOM, SHE NOTICED THAT IT SMELLED LIKE SOMETHING WAS BURNING. SHE OBSERVED THAT THE FLOW TUBE WAS BLACK. SHE HAD RESPIRATORY THERAPY PAGED TO COME TO THE ROOM. SHE THEN BEGAN TO TURN DOWN THE FLOW METER, AS SHE WAS ADJUSTING THE FLOW METER, IT EXPLODED AND FLAMES BEGAN TO SHOOT OUT OF THE WALL. A CODE RED WAS INITIATED VIA THE PHONE. THE PATIENT WAS IMMEDIATELY EVACUATED FROM THE ROOM AND THE DOOR TO THE ROOM WAS CLOSED. THE NURSING SUPERVISOR TURNED OFF THE OXYGEN TO HALF OF THE UNIT. SECURITY EXTINGUISHED THE BURNING PIECES. THERE WAS NO PATIENT HARM, EMPLOYEE INJURY OR DAMAGE TO THE FACILITY.FLOWMETER HAD BEEN IN USE FOR ALMOST 4.5 DAYS BEFORE THIS REPORTED EVENT OCCURRED.======================MANUFACTURER RESPONSE FOR OXYGEN FLOWMETER, OXYGEN FLOWMETER======================I SPOKE WITH PRECISION MEDICAL REPRESENTATIVE. HE TOOK DOWN MY INFORMATION AND A SUMMARY OF WHAT OCCURRED. HE MADE A REFERENCE THAT THERE WAS A RECALL ON THIS DEVICE IN THE LATE 1990'S. HE WAS GOING TO RESEARCH THE PREVIOUS RECALL. HE MENTIONED THAT THIS WAS THE FIRST INCIDENT WITH THIS DEVICE THAT HE WAS AWARE OF IN HIS 10 YEARS WITH THE COMPANY.