MalfunctionFMP
STATIC AIR SEAT CUSHION
Received Jan 30, 2023 · Event occurred Jan 6, 2023
Report 16263476 · MDR key 16263476
Device
Generic name
Protector, Skin Pressure
Manufacturer
Mölnlycke Health Care AbModel number
1400106Catalog number
1400106
Lot number
22340004
Product problems
- Deflation Problem
Patient
28105 DA · Male
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
WAFFLE CUSHION DEFLATED WHILE PT. WAS USING CUSHION IN CHAIR. THE CHAIR CUSHION WAS UTILIZED FOR PRESSURE REDUCTION FOR SKIN CARE. IF THIS PRODUCT IS DEFLATED, IT INCREASED THE RISK FOR HOSPITAL ACQUIRED PRESSURE INJURIES, THIS, IT HAS POTENTIAL FOR SKIN INTEGRITY IMPAIRMENT MANUFACTURER RESPONSE FOR PRESSURE REDUCTION DEVICE, STATIC AIR SEAT CUSHION (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO US PRODUCTS COMPLAINTS TEAM LEAD. COMPLAINT ASSIGNED BY MANUFACTURER AND DEVICE MAILED OUT TO THE MANUFACTURER.