inforMED
MalfunctionFMP

STATIC AIR SEAT CUSHION

Received Aug 5, 2022 · Event occurred Jun 25, 2022

Report 15174154 · MDR key 15174154

Device

Generic name

Protector, Skin Pressure

Catalog number

1400106

Lot number

22130001

Product problems

  • Unintended Deflation

Patient

23725 DA · Female

  • 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 POTENTIAL FOR SKIN INTEGRITY IMPAIRMENT. MANUFACTURER RESPONSE FOR PRESSURE REDUCTION CUSHION, STATIC AIR SEAT CUSHION (PER SITE REPORTER) EQUIPMENT FAILURE REPORTED TO PRODUCT SAFETY SPECIALIST. EQUIPMENT IS AVAILABLE FOR RETURN. RESPONSE RECEIVED FROM THE MANUFACTURER AND PRODUCT RETURNED TO THEM.