BIO-MED DEVICES

Additional Manufacturer Narrative

MANUFACTURER VERIFIED THE OBSERVATIONS OF THE HOSPITAL'S OWN CLINICAL ENGINEERING TECHNICIANS ("KNOB DAMAGED, SHAFT BENT"). THE FACE OF THE DEVICE HAD BEEN SIGNIFICANTLY IMPACTED, PROBABLY FROM A DROP ONTO A HARD FLOOR. THE CONTROL KNOB WAS CRACKED. THE METAL CONTROL SHAFT UNDERNEATH WAS BENT. THE KNOB COULD NOT BE ACTUATED IN A PROPER CIRCULAR MOTION, INSTEAD IT TURNED NOTICEABLY ASKEW, WITH CONTACT WITH THE FACE PLATE INTERFERING AT SOME ROTATION POINTS. THE MANUFACTURER REPAIRED THE DEVICE BY REPLACING THE CONTROL KNOB, AND THE ENTIRE UNDERLYING VALVE / SHAFT ASSEMBLY, THEN RE-CALIBRATING THE DEVICE.

Description of Event or Problem

BLENDER WAS PULLED OUT OF SERVICE WHEN IT WAS DETERMINED THAT THE OXYGEN % OUTPUT DID NOT MATCH KNOB SET. HOSPITAL CLINICAL ENGINEERING FOUND THE KNOB DAMAGED, WITH SHAFT BENT. BLENDER WAS RETURNED TO MFR FOR REPAIR.