MalfunctionFMP
STATIC AIR CUSHION
Received May 2, 2022 · Event occurred Apr 8, 2022
Report 14257460 · MDR key 14257460
Device
Generic name
Protector, Skin Pressure
Manufacturer
Molnlycke Health CareCatalog number
1400106
Lot number
22030003
Product problems
- Unintended Deflation
Patient
20805 DA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WAFFLE CUSHION DEFLATED WHILE ON 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 STATIC AIR SEAT CUSHION, STATIC AIR CUSHION (PER SITE REPORTER): EQUIPMENT FAILURE REPORTED TO MANUFACTURER, AND THEY ARE OPENING AN INVESTIGATION. AWAITING AN EMAIL. PRODUCT AVAILABLE FOR RETURN.