inforMED
MalfunctionFMP

STATIC AIR CUSHION

Received Jul 14, 2022 · Event occurred May 10, 2022

Report 15013694 · MDR key 15013694

Device

Generic name

Protector, Skin Pressure

Catalog number

1400106

Product problems

  • Unintended Deflation

Patient

Unknown

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

Narrative

Description of Event or Problem

WAFFLE CHAIR CUSHION FOUND DEFLATED FOLLOWING PATIENT USE. 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. NO PATIENT INJURY NOTED FOR THIS CASE.

Description of Event or Problem

WAFFLE CHAIR CUSHION FOUND DEFLATED FOLLOWING PATIENT USE. 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. NO PATIENT INJURY NOTED FOR THIS CASE.