inforMED
MalfunctionFMP

STATIC AIR SEAT CUSHION

Received May 4, 2022 · Event occurred Apr 25, 2022

Report 14280067 · MDR key 14280067

Device

Generic name

Protector, Skin Pressure

Catalog number

1400106

Lot number

22030003

Product problems

  • Deflation Problem

Patient

22630 DA · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

WAFFLE CUSHION DEFLATED WHILE PT. WAS USING CUSHION IN CHAIR. 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 PRESSURE REDUCTION CUSHION, STATIC AIR SEAT CUSHION (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO MANUFACTURER'S US PRODUCT COMPLAINT TEAM LEAD. THE TEAM LEAD INDICATED THERE IS NO NEED TO SEND PRODUCT TO MANUFACTURER DUE TO ADEQUATE PREVIOUSLY SENT EQUIPMENT FAILURES FROM SAME LOT NUMBER.