MalfunctionFMW
ISOGEL AIR
Received Jul 11, 2017 · Event occurred Jun 20, 2017
Report 6700475 · MDR key 6700475
Device
Generic name
Cover, Mattress (medical Purposes)
Manufacturer
Stryker MedicalModel number
2860-000-001Catalog number
2860-000-001
Lot number
144346, 144347
Product problems
- Delamination
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
MATTRESS COVERS ARE DELAMINATING ON THE UNDERSIDE ALLOWING FLUIDS TO POTENTIALLY ENTER THE BODY OF THE MATTRESS; DUE TO THE DESIGN OF THE INTERNAL COMPONENTS- CLEANING CAN NOT BE PROPERLY COMPLETED WITH POTENTIAL RISK FOR PATIENT EXPOSURE.