inforMED
MalfunctionIOQ

PRO+

Received May 27, 2026 · Event occurred May 1, 2026

Report 3006697241-2026-00201 · MDR key 25311530

Device

Generic name

Bed, Flotation Therapy, Powered

Model number

P3255A

Catalog number

P3255A08

Lot number

N/A

Product problems

  • Flare or Flash

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

BAXTER RECEIVED A REPORT THAT PRO+ VERSACARE HAD POWER CORD BURNT. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

THE BAXTER TECHNICAL SUPPORT REPRESENTATIVE PERFORMED TROUBLESHOOTING OVER THE PHONE WITH THE ACCOUNT, ASKING THE ACCOUNT TO REPLACE THE POWER CORD. PER THE BAXTER SERVICE MANUAL, PERFORM ANNUAL PREVENTIVE MAINTENANCE PROCEDURES TO MAKE SURE ALL VERSACARE BED COMPONENTS ARE FUNCTIONING AS ORIGINALLY DESIGNED. EXAMINE THE PLUG FOR DAMAGE. MAKE SURE THE PLUG IS A ONE-PIECE MOLDED PLUG ASSEMBLY. IF IT IS NOT, REPLACE THE PLUG CORD ASSEMBLY. REPLACE ANY PLUG CORD ASSEMBLY THAT SHOWS ANY OF THESE: DISCOLORATION OF THE PLUG MOLDING, AROUND THE PLUG BLADES. ANY SIGNS OF CRACKING., LOOSE FIT OF THE PLUG BLADE (THE PLUG BLADE MOVES IN THE MOLDING), VERIFY THAT THE STRAIN RELIEF P-CLIP IS PRESENT. REPLACE THE POWER CORD, IF DAMAGED. 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 ACCOUNT REPLACED THE POWER CORD NO FURTHER ACTION NEEDED.