inforMED
MalfunctionFMW

XPRT SLEEP SURFACE

Received Mar 24, 2014 · Event occurred Feb 28, 2014

Report 0001831750-2014-02602 · MDR key 3696184

Device

Generic name

Cover, Mattress (medical Purposes)

Catalog number

2950000000

Product problems

  • Break
  • Moisture Damage

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

FOLLOW-UP SUBMITTED TO REPORT THE MATTRESS COVER WAS REPLACED.

Additional Manufacturer Narrative

CONCLUSION: PARTS ON ORDER.

Description of Event or Problem

IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE TOP COVER WAS DAMAGED WITH FLUID INTRUSION. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

Description of Event or Problem

IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE TOP COVER WAS DAMAGED WITH FLUID INTRUSION. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.