COMPELLA SURFACE
Received Apr 2, 2025 · Event occurred Mar 26, 2025
Report 1824206-2025-00629 · MDR key 21754151
Device
Generic name
Bed, Flotation Therapy, Powered
Manufacturer
Baxter Healthcare CorporationModel number
P7810ACatalog number
P7810ARC3A0ENG1
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 SHOWED BAXTER PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN FEB 27, 2016. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. 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 CNTROLR, RNT CLRT 120V US (PRODUCT CODE P7810ARC3A0ENG1, SERIAL NUMBER (B)(6), HAD POWER CORD DAMAGED 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.