MalfunctionFNL
RAYES, INC DBA SIZEWISE MANUFACTURING
Received Jun 3, 2025 · Event occurred May 5, 2025
Report 1931307-2025-00011 · MDR key 22134330
Device
Product problems
- Connection Problem
- Connection Problem
Patient
NA · Unknown
- Fall
- Fall
Narrative
Description of Event or Problem
CUSTOMER STATES BED ALARM WORKED BUT DID NOT SIGNAL THE DESK WHEN PATIENT FELL OUT OF BED. NO PATIENT INJURIES WERE SUSTAINED.
Additional Manufacturer Narrative
THE BEDFRAME WAS EVALUATED AND IT WAS FOUND THAT THE CABLE FROM THE NURSE CALL BOX, WHICH CONNECTS TO THE REST SECURE SYSTEM AND PROVIDES CONNECTIVITY OF ANY ALARM PASSING THROUGH THE BEDFRAME, WAS RIPPED OUT OF THE BOX. REPLACEMENT OF NURSE CALL BOX WAS COMPLETED TO CORRECT THIS ISSUE.
Remedial action
- Replace