MalfunctionFMP

STATIC AIR SEAT CUSHION

Received Feb 9, 2024 · Event occurred Nov 9, 2023

Report 18675641 · MDR key 18675641

Device

Generic name

Protector, Skin Pressure

Manufacturer

Molnlycke Health Care Ab

Model number

1400106

Catalog number

1400106

Lot number

23350001

Patient

46 YR · 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 IS UTILIZED FOR PRESSURE REDUCTION FOR SKIN CARE. IF THIS PRODUCT IS DEFLATED, IT INCREASES THE RISK FOR PATIENT ACQUIRED PRESSURE INJURIES. MANUFACTURER RESPONSE FOR PRESSURE REDUCTION CUSHION, STATIC AIR SEAT CUSHION (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO COMPLAINTS.US@MOLNKLYCKE.COM. MANUFACTURER ASSIGNED CASE NUMBER. EQUIPMENT SENT OUT. COMPLAINT SAMPLES IIMED VIA FEDEX.