inforMED
MalfunctionIOQ

TOTALCARE BARIATRIC PLUS BED

Received Nov 20, 2025 · Event occurred Oct 24, 2025

Report 1824206-2025-02052 · MDR key 23609642

Device

Generic name

Bed, Flotation Therapy, Powered

Model number

P1840

Catalog number

P1840RE200

Lot number

NI

Product problems

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Patient

NA · Unknown

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

Narrative

Description of Event or Problem

BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN TO REPORT THE TC BARIATRIC PLUS W/ AIR SIDERAIL RANDOMLY FALLS. THE BED WAS LOCATED AT THE ACCOUNT. OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED. THERE WERE NO OTHER DEVICES REPORTED TO BE INVOLVED. THE CUSTOMER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.

Additional Manufacturer Narrative

THE BAXTER TECHNICIAN FOUND THE SIDERAIL CENTER ARM NEEDED TO BE REPLACED. PER THE BAXTER USER MANUAL: APPLYING MORE THAN 100 LB (45.5 KG) OF ADDITIONAL OUTWARD FORCE ON A SIDERAIL WHILE A PATIENT IS LAYING AGAINST IT MAY CREATE AN UNSTABLE BED SITUATION. CARE SHOULD BE TAKEN WHEN THE PATIENT IS AGAINST THE SIDERAIL AND OUTWARD FORCE IS USED TO MOVE THE PATIENT. FAILURE TO DO SO CAN CAUSE PERSONAL INJURY. 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 TECHNICIAN REPLACED THE SIDERAIL CENTER ARM TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.