inforMED
MalfunctionFMW

2800-000-000 35X84 P NYLA

Received Feb 11, 2014 · Event occurred Jan 14, 2014

Report 0001831750-2014-01183 · MDR key 3622731

Device

Generic name

Cover, Mattress (medical Purposes)

Catalog number

IMR000000

Product problems

  • Moisture Damage

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 TOP COVER HAD FLUID INGRESS. 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 HAD FLUID INGRESS. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

Additional Manufacturer Narrative

FOLLOW-UP SUBMITTED WITH UPDATED CONCLUSION. MATTRESS WAS SCRAPPED.