inforMED
MalfunctionIOQ

COMPELLA BARIATRIC BED

Received May 21, 2025 · Event occurred May 7, 2025

Report 1824206-2025-00922 · MDR key 22063329

Device

Generic name

Bed, Flotation Therapy, Powered

Model number

P7800A

Catalog number

P7800A000029

Product problems

  • Material Split, Cut or Torn
  • Material Split, Cut or Torn

Patient

NA · Unknown

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

Narrative

Additional Manufacturer Narrative

THE BAXTER TECHNICIAN FOUND THE POWER CORD NEEDED TO BE REPLACED. PER THE BAXTER SERVICE MANUAL IT IS NECESSARY FOR THE COMPELLA BARIATRIC BED TO HAVE AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU DO ANNUAL PREVENTIVE MAINTENANCE. PAY PARTICULAR ATTENTION TO SAFETY FEATURES, WHICH INCLUDE BUT ARE NOT LIMITED TO: THE POWER CORDS FOR THE BED AND ASU ARE WITH THE UNIT, AND THEY ARE IN GOOD CONDITION: THE PLUG IS A ONE-PIECE MOLDED PLUG ASSEMBLY, THE ASSEMBLY SHOWS NO SIGNS OF CRACKING, THE PLUG MOLDING AROUND THE BLADE IS NOT DISCOLORED, AND THE BLADE IS TIGHT IN THE MOLDING. THE POWER CORD HOOKS SHOWS NO SIGN OF CRACKING AND ARE INTACT WITH NO DAMAGE. REPLACE OR REPAIR PARTS 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 TECHNICIAN REPLACED THE POWER CORD TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem

IT WAS REPORTED THAT COMPELLA FRAME (PRODUCT CODE P7800A000029, SERIAL NUMBER (B)(6)), HAD POWER CORD DAMAGE WITH EXPOSED COPPER WIRES. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.