inforMED
MalfunctionIOQ

COMPELLA BARIATRIC BED

Received Apr 3, 2025 · Event occurred Mar 15, 2025

Report 1824206-2025-00637 · MDR key 21764340

Device

Generic name

Bed, Flotation Therapy, Powered

Model number

P7800A

Catalog number

P7800ARENT01

Product problems

  • Activation Problem
  • Activation Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE BAXTER TECHNICIAN FOUND THE CPR HANDLE AND DRIVE LUG NEEDED TO BE REPLACED. PER THE BAXTER SERVICE MANUAL THE COMPELLA BED REQUIRES AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM ANNUAL PREVENTATIVE MAINTENANCE. PAY PARTICULAR ATTENTION TO SAFETY FEATURES, WHICH INCLUDE BUT ARE NOT LIMITED TO: ALL CAREGIVER AND PATIENT CONTROLS, ALONG WITH THEIR INDICATORS, OPERATE CORRECTLY; THIS INCLUDES CONTROLS FOR CPR. REPLACE OR REPAIR PARTS AS NECESSARY. A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED ON JUN 4, 2024. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE CPR HANDLE AND DRIVE LUG TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem

IT WAS REPORTED THAT COMPELLA RENT US SCALE PD PPM (PRODUCT CODE P7800ARENT01, SERIAL NUMBER (B)(6)), CPR FEATURE WAS UNABLE TO BE ACTIVATED. THIS OCCURRED AFTER PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.