inforMED
MalfunctionFMP

STATIC AIR SEAT CUSHION

Received Jun 22, 2023 · Event occurred Mar 22, 2023

Report 17180946 · MDR key 17180946

Device

Generic name

Protector, Skin Pressure

Model number

1400106

Catalog number

1400106

Lot number

23030006

Product problems

  • Deflation Problem

Patient

30295 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 WAS UTILIZED FOR PRESSURE REDUCTION FOR SKIN CARE. IF THIS PRODUCT IS DEFLATED, IT INCREASED THE RISK FOR HOSPITAL ACQUIRED PRESSURE INJURIES, THIS, IT HAS POTENTIAL FOR SKIN INTEGRITY IMPAIRMENT. MANUFACTURER RESPONSE FOR PRESSURE REDUCTION CUSHION, STATIC AIR SEAT CUSHION (PER SITE REPORTER) EQUIPMENT FAILURE REPORTED TO REP. MAILED OUT VIA FEDEX.