inforMED
MalfunctionIOQ

PRO +

Received Apr 17, 2025 · Event occurred Mar 26, 2025

Report 3006697241-2025-00117 · MDR key 21860148

Device

Generic name

Bed, Flotation Therapy, Powered

Model number

P7923A

Catalog number

P7923A04

Lot number

UNKNOWN

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, IT IS NECESSARY FOR THE CENTRELLA BED TO HAVE AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU DO ANNUAL PREVENTIVE MAINTENANCE. MAKE SURE THE POWER CORD IS NOT DAMAGED AND IT IS CONNECTED TO THE BED. REPLACE THE POWER CORD AS NECESSARY. CHECK THE AC INLET TO PSM CABLE ASSEMBLY FOR KINKS, DAMAGE, AND CONNECTIONS. REPLACE OR CONNECT THE CABLE AS NECESSARY. REPLACE PARTS AS 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.