OXYGEN FLOWMETER 2MFA1001 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-01 for OXYGEN FLOWMETER 2MFA1001 * manufactured by Precision Medical Inc..

Event Text Entries

[17974540] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2009075
MDR Report Key2009075
Date Received2011-03-01
Date of Report2011-03-01
Date of Event2011-02-24
Report Date2011-03-01
Date Reported to FDA2011-03-01
Date Added to Maude2011-03-07
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameOXYGEN FLOWMETER
Generic NameOXYGEN FLOWMETER
Product CodeCAX
Date Received2011-03-01
Model Number2MFA1001
Catalog Number*
Lot Number*
ID Number*
OperatorNURSE
Device AvailabilityN
Device Age15 YR
Device Sequence No1
Device Event Key0
ManufacturerPRECISION MEDICAL INC.
Manufacturer Address300 HELD DRIVE NORTHAMPTON PA 18067 US 18067


Patients

Patient NumberTreatmentOutcomeDate
10 2011-03-01

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