MalfunctionFMW
XPRT W/O PENDANT W/DARTEX
Received Sep 20, 2012 · Event occurred Aug 24, 2012
Report 1313850-2012-00295 · MDR key 2760316
Device
Generic name
Mattress
Manufacturer
Stryker Corp Dba GaymarModel number
2950200002Catalog number
NA
Lot number
NA
Product problems
- Material Discolored
- Moisture Damage
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
IT HAS BEEN REPORTED THAT THE CUSTOMER FOUND THAT THERE IS A SIGNIFICANT DISCOLORATION ON THE FOAM PORTION OF THE MATTRESS NEAR THE LAL TUBING. IT IS ALLEGED THAT ON INITIAL INSPECTION THIS AREA APPEARED TO BE A LITTLE MOIST AS WELL. NO PG INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.