inforMED
MalfunctionFNL

RAYE'S, INC DBA SIZEWISE MANUFACTURING

Received Jun 12, 2025 · Event occurred May 13, 2025

Report 1931307-2025-00012 · MDR key 22198068

Device

Generic name

120v Evolution Bed W/scale 35"

Model number

33060400

Product problems

  • Sparking
  • Sparking

Patient

NA · Unknown

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

Narrative

Additional Manufacturer Narrative

DURING INSPECTION, BLACK CHARRING WAS IDENTIFIED ON THE UNDERSIDE OF THE HEAD DECK SECTION AND ON THE HEAD END OF THE FRAME AT THE MOUNTING POINT OF THE STRAIN RELIEF FOR THE POWER CORD. WHEN INSPECTING THE POWER CORD, THERE WAS ALSO AN AREA THAT HAD CHAR MARKS, SHOWING BARE METAL WIRES EXPOSED AND THE CORD WAS COMPRESSED/PINCHED IN THAT AREA. FINDINGS INDICATE POWER CORD WAS PINCHED BETWEEN THE HEAD SECTION AND BEDFRAME WHEN HEAD DECK WAS LOWERED EXPOSING BARE WIRE. CONTACT BETWEEN BARE WIRE AND METAL BED FRAME AND STRAIN RELIEF RESULTING IN SPARKING.

Description of Event or Problem

CUSTOMER REPORTED POWER CORD ON BEDFRAME WAS SPARKING WHILE IN PATIENT USE. NO PATIENT INJURIES WERE REPORTED.

Remedial action

  • Replace