ELITE
Received Sep 17, 2025 · Event occurred Aug 8, 2025
Report 23073031 · MDR key 23073031
Device
Product problems
- Leak/Splash
- Mechanical Jam
Patient
38 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PT WAS IN OPERATING ROOM HAVING A REPEAT C/S [CESAREAN SECTION] WHEN THE HYDRAULICS WENT OUT ON THE OPERATING ROOM BED IN THE MIDDLE OF THE C/S. THIS RESULTED IN THE PT. IN SEVERE TRENDELENBURG ON THE BED. MULTIPLE NURSES, TECHS AND ANESTHESIOLOGIST HAD TO MANUALLY HOLD UP THE BED SO THE OBSTETRICIANS COULD CLOSE HER ABDOMEN. THE OBS HAD TO RUSH THE CASE AND CLOSE WITH STAPLES SO WE COULD MOVE HER OF THE OPERATING ROOM BED AND ONTO A GURNEY. MEANWHILE THE BED WAS LEAKING HYDRAULIC FLUID ALL OVER THE OR FLOOR MAKING THE FLOOR EXTREMELY SLIPPERY PUTTING THE STAFF AT RISK FOR FALLS. -REACHED OUT TO [REDACTED] & L&D [LABOR AND DELIVERY] LEADERSHIP TO CONFIRM MAINTENANCE -LAST MAINTENANCE WAS [DATE REDACTED] - APPROXIMATELY 3 MONTHS AGO - WITH NEXT ONE SCHEDULED [DATE REDACTED] - IN APPROXIMATELY 2.5 MONTHS. OPERATIVE REPORT "DURING CLOSURE OF THE FASCIAL LAYER THE OR BED SPONTANEOUSLY MOVED TO LOWER HEIGHT AND WENT INTO TRENDELENBURG; HYDRAULIC FLUID NOTED ALL OVER FLOOR. THE BED WAS PHYSICALLY KEPT IN PLACE BY ANESTHESIA (AT HEAD OF BED) AND RN (AT FOOT OF BED) WHO WERE EACH PHYSICALLY SUPPORTING EITHER ENDS SO THAT THE BED WOULD NOT FURTHER MOVE DURING CLOSURE. THE SKIN WAS CLOSED WITH STAPLES. THE INCISION WAS COVERED WITH A BANDAGE AND THE PATIENT WAS TRANSFERRED TO THE GURNEY." [DATE REDACTED] -L&D OR TABLE - CURRENT STATUS: SHIPPED TO VENDOR FOR EVALUATION AND REPAIR.