inforMED
MalfunctionFNL

RAYES, INC DBA SIZEWISE MANUFACTURING

Received Jun 3, 2025 · Event occurred May 5, 2025

Report 1931307-2025-00011 · MDR key 22134330

Device

Generic name

Bswrp2 86

Model number

12060308

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