inforMED
MalfunctionIOQ

PRO+

Received Oct 15, 2025 · Event occurred Sep 24, 2025

Report 3006697241-2025-00278 · MDR key 23301313

Device

Generic name

Bed, Flotation Therapy, Powered

Model number

P3255A02

Catalog number

P3255A02

Lot number

NI

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. 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 DEVICE. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR DEVICES. 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

BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN TO REPORT THE PRO+ VERSACARE MRS W/O X-RAY POWER CORD HAD COPPER WIRES EXPOSED. THE BED WAS LOCATED AT THE ACCOUNT. THIS OCCURRED DURING BAXTER SERVICING/TESTING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED. THERE WAS A SECOND DEVICE ALSO REPORTED TO BE INVOLVED: MODEL NUMBER: P3200 SERIAL NUMBER: (B)(6). THE CUSTOMER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.