MalfunctionFMP
STATIC AIR SEAT CUSHION
Received May 4, 2022 · Event occurred Apr 3, 2022
Report 14280345 · MDR key 14280345
Device
Generic name
Protector, Skin Pressure
Manufacturer
Molnlycke Health CareCatalog number
1400106
Lot number
22030003
Product problems
- Deflation Problem
Patient
31390 DA · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
WAFFLE CHAIR CUSHION FOUND DEFLATED FOLLOWING PATIENT USE. THE CHAIR CUSHION IS UTILIZED FOR PRESSURE REDUCTION FOR SKIN CARE. IF THIS PRODUCT IS DEFLATED, IT INCREASES THE RISK FOR HOSPITAL ACQUIRED PRESSURE INJURIES. THUS, IT HAS THE POTENTIAL FOR SKIN INTEGRITY IMPAIRMENT. MANUFACTURER RESPONSE FOR WAFFLE CHAIR CUSHION, STATIC AIR SEAT CUSHION (PER SITE REPORTER). EQUIPMENT FAILURE TREND REPORTED TO MANUFACTURER. EQUIPMENT WILL BE SENT BACK TO MANUFACTURER FOR INVESTIGATION OF FAILURE.