MalfunctionFMP
STATIC AIR SEAT CUSHION
Received Nov 8, 2023 · Event occurred Sep 12, 2023
Report 18091344 · MDR key 18091344
Device
Generic name
Protector, Skin Pressure
Manufacturer
Molnlycke Health Care AbModel number
1400106Catalog number
1400106
Lot number
23300005
Patient
27740 DA · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
WAFFLE CUSHION DEFLATED WHILE PATIENT WAS USING CUSHION IN CHAIR. THE CHAIR CUSHION WAS UTILIZED FOR PRESSURE REDUCTION FOR SKIN CARE. IF THIS PRODUCT IS DEFLATED, IT INCREASES THE RISK FOR HOSPITAL ACQUIRED PRESSURE INJURES. MANUFACTURER RESPONSE FOR PRESSURE REDUCTION CUSHION, STATIC AIR SEAT CUSHION (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO REPRESENTATIVE. EQUIPMENT RETURNED FIVE DAYS LATER WITH MAILING LABEL PROVIDED BY MANUFACTURER FEDEX TRACKING NUMBER.