STATIC IAR SEAT CUSHION
Received Jun 14, 2022 · Event occurred May 10, 2022
Report 14685040 · MDR key 14685040
Device
Generic name
Protector, Skin Pressure
Manufacturer
Molnlycke Health CareCatalog number
1400106
Lot number
21470010
Product problems
- Unintended Deflation
Patient
18615 DA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WAFFLE CUSHION DEFLATED WHILE PATIENT WAS USING CUSHION IN CHAIR. THE CHAIR CUSHION IS UTILIZED FOR PRESSURE REDUCTION FOR SKIN CARE. IF THIS PRODUCT IS DEFLATED, IT INCREASED THE RISK FOR HOSPITAL ACQUIRED PRESSURE INJURIES. THUS, IT HAS THE POTENTIAL FOR SKIN INTEGRITY IMPAIRMENT. MANUFACTURER RESPONSE FOR PRESSURE REDUCTION CUSHION, STATIC IAR SEAT CUSHION (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO MANUFACTURER'S PRODUCT SAFETY SPECIALIST. EQUIPMENT IS AVAILABLE FOR RETURN. LATER, COMMUNICATION RECEIVED FROM PRODUCT SAFETY SPECIALIST INDICATING SAMPLE IS NOT NEEDED FOR RETURN. SAMPLE DISCARDED.