RAYE'S, INC DBA SIZEWISE MANUFACTURING
Received Jun 12, 2025 · Event occurred May 13, 2025
Report 1931307-2025-00012 · MDR key 22198068
Device
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