MalfunctionFMP
Z-FLO
Received Sep 1, 2011 · Event occurred Aug 31, 2011
Report 2233075 · MDR key 2233075
Device
Generic name
Fluidized Positioner, Patient Positioner
Manufacturer
Sundance EnterprisesModel number
Z-FLOCatalog number
*
Lot number
1 7/041811/173, /164,/165
Product problems
- Burst Container or Vessel
Patient
*
- No Information
Narrative
Description of Event or Problem
UNIT NURSES EXPERIENCED THREE Z-FLO BRAND FLUIDIZED POSITIONER PACKS THAT BURST RESULTING IN RELEASE OF THE CONTENTS IN THE PACK. THE PACKS WERE BEING USED TO POSITION THE PATIENTS' HEADS OR UPPER BODY AREAS. UNITS WERE SENT TO BIOMEDICAL FOR EVALUATION.======================MANUFACTURER RESPONSE FOR FLUIDIZED POSITIONER, PATIENT POSITIONER, Z-FLO (PER SITE REPORTER)======================MANUFACTURER REPRESENTATIVE TO PICK UP 3 DEVICES.