STATIC AIR SEAT CUSHION
Received Aug 5, 2022 · Event occurred Jun 22, 2022
Report 15174104 · MDR key 15174104
Device
Generic name
Protector, Skin Pressure
Manufacturer
Molnlyck Health CareCatalog number
1400106
Lot number
22130001
Product problems
- Deflation Problem
Patient
23725 DA · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
WAFFLE CUSHION DEFLATED WHILE PT. WAS USING CUSHION IN CHAIR. 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 POTENTIAL FOR SKIN INTEGRITY IMPAIRMENT. MANUFACTURER RESPONSE FOR PRESSURE REDUCTION CUSHION, STATIC AIR SEAT CUSHION (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO PRODUCT SAFETY SPECIALIST. EQUIPMENT IS AVAILABLE FOR RETURN. RESPONSE RECEIVED FROM THE MANUFACTURER AND PRODUCT RETURNED TO THEM.