TOTALCARE BARIATRIC PLUS BED

Additional Manufacturer Narrative

UPON INSPECTION, BAXTER TECHNICIAN RAN A FUNCTION TEST ON THE HEAD SECTION. PER THE BAXTER SERVICE MANUAL THE TOTALCARE BED SYSTEM REQUIRES AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM A SEMI-ANNUAL PREVENTATIVE MAINTENANCE. PREVENTATIVE MAINTENANCE WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. TEST THE HEAD SECTION SLIDE PIVOTS, SELF-LUBRICATING BEARING, AND SLIDER PIVOT EXTRUSIONS. LOOK FOR DAMAGE, AND MAKE SURE THE HEAD SECTION OPERATES CORRECTLY. REPLACE COMPONENTS AS NECESSARY. A SEARCH OF THE BAXTER MAINTENANCE RECORDS DID NOT SHOW BAXTER PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. 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 SECTION NOT GOING UP 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 TOTALCARE BARIATRIC CAPITAL THE HEAD OF THE BED WILL NOT RISE UP. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

AFTER FURTHER REVIEW OF THE EVENT DETAILS, IT HAS BEEN DETERMINED THAT THE ARPC OF ARTICULATION: HEAD ARTICULATION UNABLE TO BE RAISED-F393 WAS INCORRECTLY ASSESSED FOR REPORTABILITY BASED ON TECH SERVICE INFORMATION THE CORRECT ARPC IS ARTICULATION: THIGH/KNEE ARTICULATION INOPERATIVE, INCORRECT MOVEMENTS OR UNRELIABLE-F036 BASED ON FDA REQUIREMENTS AND IN CONJUNCTION WITH THE BAXTER DEVICE VIGILANCE ASSESSMENT DOCUMENT AND DETERMINED TO BE NOT REPORTABLE. *PER DVAD: THE COMPLAINT INFORMATION ALONG WITH THE ARPC OF ARTICULATION: THIGH/KNEE ARTICULATION INOPERATIVE, INCORRECT MOVEMENTS OR UNRELIABLE-F036 WAS ASSESSED FOR REPORTABILITY BASED ON FDA REQUIREMENTS AND IN CONJUNCTION WITH THE BAXTER DEVICE VIGILANCE ASSESSMENT DOCUMENT AND DETERMINED TO BE NOT REPORTABLE. AN INOPERATIVE THIGH/KNEE ARTICULATION OR INCORRECT MOVEMENT, SUCH AS KNEE/FOOT DRIFTING OR RETRACT FUNCTION NOT WORKING, IN RESPONSE TO USER ACTION WOULD BE UNLIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THIS WERE TO RECUR. IN AN EVENT WHEN KNEE/FOOT DRIFTING OCCURS, A KNEE/FOOT DRIFT IS A SLOW AND GRADUAL MOTION OVER A CERTAIN PERIOD OF TIME. THE BED HAS A TILT/REVERSE TILT ANGLE INDICATOR FUNCTION THAT WOULD INDICATE TO THE CAREGIVER WHAT THE CURRENT ANGLE IS BETWEEN THE PRODUCT'S TILT PLATFORM AND STATIONARY PLATFORM. THE END USER HAS AN OPTION TO REPLACE THE BED OR USE A DIFFERENT WAY TO MODIFY THE PATIENT¿S POSITIONING. AFTER CONSIDERATION FOR POTENTIAL HARMS AND WORST-CASE SCENARIOS, NO SERIOUS ADVERSE HEALTH CONSEQUENCE WOULD OCCUR FROM THIS ISSUE.