inforMED
MalfunctionIOQ

PROGRESSA PLUS BED

Received Nov 6, 2025 · Event occurred Oct 10, 2025

Report 1824206-2025-01940 · MDR key 23486992

Device

Generic name

Bed, Flotation Therapy, Powered

Model number

P7501A

Catalog number

P7501A001971

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 AUXILIARY 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 AUXILIARY 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 PROGRESSA PLUS AUXILIARY POWER CORD HAD COPPER WIRES EXPOSED. THE BED WAS LOCATED AT THE ACCOUNT. THIS OCCURRED AFTER PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED. IT WAS UNKNOWN IF ANY SECOND DEVICE WAS ALSO INVOLVED. THE CUSTOMER DID NOT KNOW IF THIS EVENT WAS ALREADY COMMUNICATED TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.