InjuryCAP
NINGBO HENGFEUG PRESSURE GAUGE MFG CO.
Received Nov 13, 2009
Report 1832475-2009-00001 · MDR key 2623150
Device
Generic name
Pressure Gauge 868-2610
Manufacturer
Ningbo Heugfeug Pressure Gauge MfgModel number
OXYGEN PRESSURE GAUGECatalog number
NA
Lot number
NA
Product problems
- Component(s), broken
- Fire
- Out-Of-Box Failure
Patient
Not reported
- Burn(s)
- Asphyxia
- Breathing difficulties
Narrative
Description of Event or Problem
(B)(4) HAS IMPORTED PRESSURE GAUGES DESIGNED TO BE USED ON MEDICAL GAS REGULATORS THAT FELL APART DURING NORMAL USE. HIGH PRESSURE OXYGEN LEAKS FROM FAULTY GAUGES THAT CAUSE LOSS OF GAS. HIGH PRESSURE OXYGEN LEAKS CAN ALSO BE SAFETY ISSUES. (B)(4) CLAIMS GAUGES ARE APPROVED FOR MEDICAL USE. (B)(6) BELIEVES THESE GAUGES ARE NOT SUITABLE FOR USE WITH MEDICAL GAS REGULATOR.