TOTALCARE BARIATRIC PLUS BED

Additional Manufacturer Narrative

UPON INSPECTION, BAXTER TECHNICIAN RAN A FUNCTION TEST ON THE TOTALCARE BARIATRIC BED.THE BAXTER TECHNICIAN THOROUGHLY INSPECTED THE BED AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE BED FUNCTIONED AS DESIGNED. HOWEVER, IF THE REPORTED EVENT OF A HEAD OF BED NOT RAISING WERE TO RECUR, IT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY, THEREFORE BAXTER CONSIDERS THIS EVENT REPORTABLE.

Description of Event or Problem

BAXTER RECEIVED A REPORT THAT TC BARIATRIC PLUS W/ AIR HAD HEAD OF BED NOT RAISING. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.