UNKNOWN_MEDICAL_PRODUCT
Received Mar 22, 2013 · Event occurred Feb 26, 2013
Report 0001831750-2013-02274 · MDR key 3016380
Device
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 MATTRESS FOAM HAD FLUID INGRESS. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Additional Manufacturer Narrative
UNIT WILL BE SCRAPPED BY CUSTOMER.
Additional Manufacturer Narrative
IT WAS INITIALLY REPORTED THAT THE MATTRESS WAS STAINED FROM FLUID INGRESS. FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINED THE DISCOLORATION WAS DUE TO ADHESIVE OXIDATION. THIS IS NOT LIKELY TO HARM THE PATIENT AS NO MATTRESS FUNCTION WAS AFFECTED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WAS TO RECUR.
Description of Event or Problem
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE MATTRESS FOAM HAD FLUID INGRESS. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.