inforMED
MalfunctionFMW

XPRT SLEEP SURFACE

Received Apr 9, 2013 · Event occurred Mar 15, 2013

Report 0001831750-2013-03040 · MDR key 3043519

Device

Generic name

Cover, Mattress (medical Purposes)

Catalog number

2950000000

Product problems

  • Moisture Damage
  • Peeled/Delaminated
  • Delamination

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE MATTRESS HAD FLUID INTRUSION DUE TO PEELING AND DELAMINATION. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

Additional Manufacturer Narrative

MATTRESS COVER WAS REPLACED.