inforMED
MalfunctionFMP

SQUISHON MATTRESS

Received May 4, 2015 · Event occurred Apr 24, 2015

Report 4765080 · MDR key 4765080

Device

Generic name

Mattress Skin Protector

Model number

*

Catalog number

91017

Lot number

*

Product problems

  • Material Discolored
  • Material Integrity Problem

Patient

*

  • No Patient Involvement

Narrative

Description of Event or Problem

INFANT TRANSPORT MATTRESS WAS REMOVED FROM WARMER AND HAD COLOR AND COMPOSITION CHANGE. THE ROBERTS VALVE IS VERY EASY TO OPEN. THE MATTRESS HAD STORED IN A WARMER FOR APPROXIMATELY 6 MONTHS.THIS WAS NOTED PRIOR TO PATIENT USE AND TAKEN OUT OF SERVICE.CONTENTS LISTED AS: WATER, NON-TOXIC CARBOXY VINYL AND ANTI-BACTERIAL AGENT.