STATIC AIR SEAT CUSHION
Received May 4, 2022 · Event occurred Apr 1, 2022
Report 14280024 · MDR key 14280024
Device
Generic name
Protector, Skin Pressure
Manufacturer
Molnlycke Health CareCatalog number
1400106
Lot number
22100001
Product problems
- Deflation Problem
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
WAFFLE CUSHION DELATED FOLLOWING USE. THE CHAIR CUSHION WAS UTILIZED FOR PRESSURE REDUCTION FOR SKIN CARE. IF THIS PRODUCT IS DEFLATED, IT INCREASES THE RISK FOR SKIN CARE. IF THIS PRODUCT IS DEFLATED, IT INCREASES THE RISK FOR HOSPITAL ACQUIRED PRESSURE INJURIES. THUS, THERE IS A POTENTIAL FOR SKIN INTEGRITY IMPAIRMENT. MANUFACTURER RESPONSE FOR PRESSURE REDUCTION CUSHION, STATIC AIR SEAT CUSHION (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO MANUFACTURER'S U.S. PRODUCT COMPLAINT TEAM LEAD. TEAM LEAD PROVIDED MAILING LABEL FOR RETURN TO MANUFACTURER FOR INVESTIGATION.