inforMED
MalfunctionFMP

STATIC AIR SEAT CUSHION

Received Jan 3, 2023 · Event occurred Aug 21, 2022

Report 16085719 · MDR key 16085719

Device

Generic name

Protector, Skin Pressure

Catalog number

1400106

Lot number

22220003

Product problems

  • Unintended Deflation

Patient

24090 DA · Male

  • 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 INCREASES THE RISK FOR HOSPITAL ACQUIRED PRESSURE INJURIES. THUS, IT HAS POTENTIAL FOR SKIN INTEGRITY IMPAIRMENT. MANUFACTURER RESPONSE FOR PRESSURE REDUCTION DEVICE, STATIC AIR SEAT CUSHION (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED VIA EMAIL TO MANUFACTURER'S U.S. PRODUCT COMPLAINTS TEAM LEAD. EQUIPMENT TO BE RETURNED TO MANUFACTURER.