MalfunctionCCC
ABG MODULE
Received Nov 7, 1996 · Event occurred Oct 15, 1996
Report 2124823-1996-00023 · MDR key 49429
Device
Generic name
Arterial Blood Gas Analyzer
Manufacturer
Marquette ElectronicsModel number
NACatalog number
NA
Lot number
NA
Product problems
- Misassembled
- Misplacement
Patient
NA
Narrative
Description of Event or Problem
A DISTRIBUTOR REPORTED THAT ONE ANALYZER WAS FOUND TO HAVE ITS OPTICAL FILTERS INTERCHANGED. THIS WAS FOUND DURING THEIR INCOMING INSPECTION. INVESTIGATION OF THIS INCIDENT DETERMINED THAT THE ORDER OF THESE FILTERS, IF INTERCHANGED COULD AFFECT THE ACCURACY OF PT READINGS. A PROCESS HAS BEEN IMPLEMENTED IN MFG TO INSURE EACH PARAMETER IS PAIRED WITH ITS CORRESPONDING OPTICAL FILTER.
Remedial action
- Notification
- Inspection