MalfunctionFMP
STATIC AIR CUSHION
Received Jul 14, 2022 · Event occurred May 7, 2022
Report 15013608 · MDR key 15013608
Device
Product problems
- Unintended Deflation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WAFFLE CHAIR CUSHION FOUND DEFLATED FOLLOWING 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.
Description of Event or Problem
WAFFLE CHAIR CUSHION FOUND DEFLATED FOLLOWING 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.