MalfunctionLHC
WARMER DRAPE
Received Jan 11, 2017 · Event occurred Oct 25, 2016
Report 8043817-2017-00002 · MDR key 6241356
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-188231Lot number
UNKNOWN
Product problems
- Torn Material
Patient
37 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SINCE THERE WAS NO LOT NUMBER OR DEFECTIVE PRODUCT PROVIDED, THE NON-CONFORMITY COULD NOT BE VERIFIED. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.
Description of Event or Problem
END USER NOTED A SLIT IN THE FLUID WARMER DRAPE. THERE WERE NO PATIENT INJURY OR TREATMENT REPORTED FOR THE INCIDENT.