inforMED
MalfunctionIOQ

SYNERGY SURFACE

Received Aug 14, 2025 · Event occurred Jul 30, 2025

Report 1824206-2025-01428 · MDR key 22809800

Device

Generic name

Bed, Flotation Therapy, Powered

Model number

P6881

Catalog number

P6881

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. PER THE BAXTER SERVICE MANUAL INSPECT POWER CORD FOR DAMAGE, TWISTING AND REPLACE IF NECESSARY. 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.

Description of Event or Problem

BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN TO REPORT THE BLOWER ASSEMBLY, SAE 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. THERE WERE NO OTHER DEVICES REPORTED TO BE INVOLVED. THE CUSTOMER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.