inforMED
MalfunctionFMP

STATIC AIR SEAT CUSHION

Received Jun 14, 2022 · Event occurred Apr 29, 2022

Report 14685074 · MDR key 14685074

Device

Generic name

Protector, Skin Pressure

Catalog number

1400106

Lot number

22100001

Product problems

  • Unintended Deflation

Patient

26280 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 AIR 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.