OMNI
Received Aug 21, 2015 · Event occurred May 28, 2015
Report 1823260-2015-04005 · MDR key 5022871
Device
Generic name
Blood Gas Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
03337154001
Lot number
NA
Product problems
- Device Emits Odor
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEY PERCEIVED A CHARRED SMELL OF THE DEVICE. THE CUSTOMER SWITCHED OFF THE SYSTEM. NO ADVERSE EVENTS OCCURRED FOR THIS EVENT. THE FIELD SERVICE ENGINEER CHANGED THE POWER SUPPLY OF THE DEVICE. WITH THE NEW POWER SUPPLY, THE DEVICE WAS SAID TO BE WORKING FINE. THE AFFECTED POWER SUPPLY WAS INVESTIGATED. THE FIRST VISUAL INSPECTION SHOWED NO SIGN OF BURNING ON THE ELECTRONIC COMPONENTS. A FAINT SMELL OF BURNED COMPONENTS COULD BE DETECTED NEAR THE POWER SUPPLIER BOX. THE OPENED POWER SUPPLY SHOWED A LOT OF DUST INSIDE. UPON FURTHER INVESTIGATION OF THE POWER SUPPLY UNIT, A DEFECTIVE BLOWN VARISTOR WAS FOUND WITHIN THE POWER SUPPLY. THERE WAS VISUAL EVIDENCE THAT THE PART HAD BURNED OR MELTED. THE INPUT FUSE ON THE AC/DC MODULE WAS ALSO BLOWN. THE VARISTOR IS RESPONSIBLE FOR LIMITING OVERVOLTAGE. IF THE ENERGY IS TOO HIGH, THE VARISTOR WILL BE DESTROYED AND OFTEN CAUSE A SHORT CIRCUIT. THE SHORT CIRCUIT CAUSES THE INPUT FUSE OF THE AC/DC MODULE TO BLOW AND CAUSED THE BURNING SMELL. NO SPECIFIC CAUSE OF THE VARISTOR FAILURE COULD BE DETECTED. IT IS ASSUMED THAT THE FAILURE WAS DUE TO AGING OF THE VARISTOR. THE RISK OF FIRE IS HIGHLY UNLIKELY AS THE SURROUNDING MATERIAL OF THE DEFECTIVE VARISTOR IS FIRE RETARDANT MATERIAL.