MalfunctionIOQ

STRYKER ISOFLEX MATTRESS AND FOAM

Received Oct 25, 2024 · Event occurred Oct 16, 2024

Report MW5161668 · MDR key 20545675

Device

Generic name

Bed, Flotation Therapy, Powered

Manufacturer

Stryker Medical

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

WE COMPLETED AN INITIAL AUDIT IN DIFFERENT LOCATIONS OF 25% OF ALL INPATIENT STRETCHERS TO DETERMINE IF FLUID HAS INFILTRATED THE MATTRESS COVER, DURING THIS AUDIT WE FOUND 15 COMPROMISED MATTRESSES. THE SEVERITY RANGING BETWEEN EACH MATTRESS. REFERENCE REPORTS: MW5161665, MW5161666, MW5161667, MW5161669, MW5161670, MW5161671, MW5161672, MW5161673, MW5161674, MW5161675, MW5161676, MW5161677, MW5161678, MW5161679.