MalfunctionFMP
PROTECTOR, SKIN PRESSURE
Received May 2, 2022 · Event occurred Apr 7, 2022
Report 14257449 · MDR key 14257449
Device
Generic name
Protector, Skin Pressure
Manufacturer
Molnlycke Health CareCatalog number
1400106
Lot number
21520001
Product problems
- Deflation Problem
Patient
31390 DA · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
WAFFLE CHAIR CUSHION WAS FOUND DELATED AFTER 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 CHAIR CUSHION, (BRAND NOT PROVIDED) (PER SITE REPORTER). EQUIPMENT FAILURE TREND REPORTED TO (B)(6) HEALTH CARE CUSTOMER SERVICE. EQUIPMENT AVAILABLE FOR RETURN.