MalfunctionFNL
RAYES, INC DBA SIZEWISE MANUFACTURING
Received Jun 4, 2025 · Event occurred Apr 24, 2025
Report 1931307-2025-00015 · MDR key 22146310
Device
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE BEDFRAME WAS EVALUATED AND FOUND THAT CUSTOMER WAS OVERINFLATING MATTRESS ON BEDFRAME, WHICH IN TURN PRESSES ON THE SIDERAIL AND MAKES IT DIFFICULT TO MOVE THE SIDERAIL. NO ISSUES WERE IDENTIFIED WITH THE SIDERAIL.
Description of Event or Problem
FACILITY STATES THE RH SIDERAIL BUTTON WOULD NOT ENGAGE IN ORDER TO LET THE SIDERAIL DOWN. 6/4/2025 RECEIVED CONFIRMATION THAT PATIENT WAS ON BEDFRAME AT TIME OF REPORTED ISSUE.
Remedial action
- Replace
- Other