MalfunctionFMP

STATIC AIR SEAT CUSHION

Received Mar 18, 2022 · Event occurred Feb 15, 2022

Report 13807572 · MDR key 13807572

Device

Generic name

Static Air Seat Cushion

Manufacturer

Molnlycke Health Care

Catalog number

1400106

Lot number

21470009

Product problems

Deflation Problem

Patient

25550 DA · Male

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

HOSPITAL BASED SKILLED NURSING FACILITY (SNF) USING NEW DESIGN OF WAFFLE CUSHION WHICH WAS FOUND DEFLATED UNDER PATIENT 2 TIMES. MANUFACTURER RESPONSE FOR STATIC AIR SEAT CUSHION, STATIC AIR SEAT CUSHION (PER SITE REPORTER). EFFECTED LOT NUMBER OF PRODUCT PULLED FROM STOCK PER MATERIALS MANAGEMENT. DEVICE RETURNED TO THE MANUFACTURER.