MalfunctionFMP
STATIC AIR SEAT CUSHION
Received May 4, 2022 · Event occurred Apr 6, 2022
Report 14280374 · MDR key 14280374
Device
Generic name
Protector, Skin Pressure
Manufacturer
Molnlycke Health CareCatalog number
1400106
Lot number
22030003
Product problems
- Deflation Problem
Patient
30295 DA · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
CHAIR CUSHION WAS FOUND DEFLATED WHILE BEING USED BY PATIENT. 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'S CUSTOMER SERVICE. EQUIPMENT WILL BE RETURNED TO MANUFACTURER FOR INVESTIGATION.