inforMED
MalfunctionIOQ

ENVISION BLOWER KIT

Received Oct 9, 2025 · Event occurred Sep 16, 2025

Report 1824206-2025-01747 · MDR key 23256281

Device

Generic name

Bed, Flotation Therapy, Powered

Model number

P136026

Catalog number

P136026

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

BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE POWER CORD HAD DAMAGE WITH EXPOSED COPPER WIRES. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED.

Additional Manufacturer Narrative

THE BAXTER TECHNICIAN FOUND THE POWER CORD NEEDED TO BE REPLACED. PER THE BAXTER SERVICE MANUAL, EXAMINE THE POWER CORD AND ITS PLUG FOR DAMAGE. EXAMINE THE LENGTH OF THE POWER CORD FOR CUTS AND ABRASIONS. PLUG THE POWER CORD INTO A CALIBRATED SAFETY ANALYZER AND ATTACH THE ANALYZER TO THE EXPOSED METAL CHASSIS GROUND TEST POINT TO MAKE SURE THE GROUND RESISTANCE IS NO MORE THAN 200 MILLIOHMS. PLUG THE POWER CORD INTO A CALIBRATED SAFETY ANALYZER AND MAKE SURE THE LEAKAGE CURRENT IS NO MORE THAN 300 MICROAMPS IN NORMAL CONDITION (NC). REPLACE AS NECESSARY. A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER DID NOT PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE POWER CORD TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.