MalfunctionBXK
NA
Received Oct 12, 2005 · Event occurred Oct 5, 2005
Report 2518435-2005-00007 · MDR key 695473
Device
Generic name
Calibration Gas
Manufacturer
Scott Medical ProductsModel number
NACatalog number
237-2120-300
Lot number
527201
Product problems
- Leak/Splash
- Material Separation
- Valve(s), failure of
Patient
NA
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
SCOTT MEDICAL PRODUCTS PRODUCES CALIBRATION GAS MIXTURES IN AEROSOL STYLE CYLINDERS (7 INCHES TALL X 2.5 INCHES IN DIAMETER HOLDING 4 LITERS OF GAS) FOR DATEX-OHMEDA. THE BUYER FROM DATEX-OHMEDA REPORTED THAT THE CYLINDER VALVE SEPARATED FROM THE CYLINDER FROM A RECENT SHIPMENT RELEASING THE GAS. THE CYLINDER WAS SITTING ON A STORAGE SHELF WHEN THE VALVE RELEASED.
Remedial action
- Other