inforMED
MalfunctionIOQ

PRO+

Received Sep 16, 2025 · Event occurred Aug 20, 2025

Report 3006697241-2025-00245 · MDR key 23064024

Device

Generic name

Bed, Flotation Therapy, Powered

Model number

P3255A02

Catalog number

P3255A02

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

Description of Event or Problem

DURING SERVICING BY BAXTER, TECHNICAL SERVICE IDENTIFIED THAT PRO+ VERSACARE MRS W/O X-RAY (PRODUCT CODE P3255A02, SERIAL NUMBER (B)(6)), HAD POWER CORD DAMGED WITH COPPER WIRES EXPOSED. THIS OCCURRED DURING BAXTER SERVICING/TESTING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

THE BAXTER TECHNICIAN FOUND THE POWER CORD NEEDED TO BE REPLACED. IT IS NECESSARY FOR THE PRO+ MATTRESS TO HAVE AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU DO ANNUAL PREVENTIVE MAINTENANCE (PM) AND TESTING FOR JOINT COMMISSION CERTIFICATION. EXAMINE THE ENTIRE LENGTH OF THE MATTRESS POWER CORD. MAKE SURE THERE ARE NO CUTS OR EXPOSED WIRES. MAKE SURE THE PLUG IS A ONE-PIECE MOLDED PLUG ASSEMBLY. EXAMINE THE PLUG FOR DAMAGE. REPLACE THE MATTRESS POWER CORD IF THE PLUG SHOWS: DISCOLORATION OF THE PLUG MOLDING ON OR AROUND THE PLUG BLADES. SIGNS OF CRACKING. LOOSE FIT OF THE PLUG BLADE (THE PLUG BLADE MOVES IN THE MOLDING). 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.