inforMED
MalfunctionFNL

DIRECT SUPPLY

Received Mar 27, 2025 · Event occurred Jan 9, 2025

Report 1931947-2025-00001 · MDR key 21708862

Device

Generic name

Bed - Pan3500, Mah W/safety Lock - 80-84" X 35-42" (beige)

Model number

1070014BEI

Catalog number

C7570

Product problems

  • Human-Device Interface Problem
  • Human-Device Interface Problem

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

CUSTOMER REPORTED THE ARM WITH THE WHEEL ON IT BECAME SEPARATED FROM THE FRAME, CAUSING THE HEAD OF THE BED TO COME CRASHING DOWN. CUSTOMER DID NOT REPORT A PATIENT IN THE BED. WE ARE SENDING A NEW LEG AND REQUESTING THE LEG IN QUESTION BE RETURNED FOR INVESTIGATION TO DETERMINE IF A MALFUNCTION OCCURED. WE ARE REPORTING WITH THE INFORMATION PROVIDED OUT OF AN ABUNDANCE OF CAUTION.

Additional Manufacturer Narrative

LEG RETURNED FOR EVALUATION. LEG IS BENT WITH ONE LEG HIGHER THAN THE OTHER WHICH PULLS THE LEG INWARD MAKING THE NLYON ROLLER RIDE ON THE EDGE OF THE CHANNEL AND/OR TRAVEL DOWN THE CHANNEL AT AN ANGLE CREATING A WEAR SPOT ON THE ROLLER. LEG COULD BE BENT DUE TO POSSIBLE OVERLOADING OR HANGING UP ON SOMETHING SUCH AS A WINDOWSILL, FURNITURE IN THE ROOM, VISITOR SITTING ON THE BED, LOWERING BED DOWN ON SOMETHING UNDER THE BED, USING A LIFT THAT DID NOT OFFER ENOUGH CLEARANCE AND HITTING THE LEG, ETC. CAUSING THE LEG TO BEND. LEG HAD MARKS ON THE INSIDE AND OUTSIDE EDGE UNDER THE LEGS INDICATING IT HAD BEEN POSSIBLY BEEN HIT FROM THE SIDE, RUBBED OR SCUFFED UNDERNEATH OR FELL ONTO SOMETHING THAT WAS UNDER THE BED. LEG WAS INSTALLED ON A BED AND MAXIMUM WEIGHT (SAFE WORKING LOAD) WAS PLACED ON THE BED AND TESTED FOR 7 DAYS. WE COULD NOT RECREATE THE LEG COMING OUT OF THE CHANNEL. PREVIOUS TESTING FOUND THE ONLY WAY WE COULD RECREATE THE LEG COMING OUT OF THE CHANNEL WAS IF THE BED WAS LOADED WITH MAXIMUM WEIGHT, HAD A BENT ARM AND BENT LEG AND IT WAS PREVENTED FROM MOVING UP AND THE UP BUTTON CONTINUED TO BE PRESSED THUS BENDING THE LEG AND FORCING IT OUT OF THE CHANNEL. REPORT FILED (B)(6) 2025, FOUND ON (B)(6) 2025 DURING FOLLOW UP REPORTING THAT THE ORIGINAL REPORT WAS NOT RECEIVED. THIS REPORT ENCOMPASSES THE INITIAL AND FOLLOW UP REPORTS.

Description of Event or Problem

CUSTOMER REPORTED THE ARM WITH THE WHEEL ON IT BECAME SEPARATED FROM THE FRAME, CAUSING THE HEAD OF THE BED TO COME CRASHING DOWN. CUSTOMER DID NOT REPORT A PATIENT IN THE BED. WE ARE SENDING A NEW LEG AND REQUESTING THE LEG IN QUESTION BE RETURNED FOR INVESTIGATION TO DETERMINE IF A MALFUNCTION OCCURED. WE ARE REPORTING WITH THE INFORMATION PROVIDED OUT OF AN ABUNDANCE OF CAUTION.

Additional Manufacturer Narrative

LEG RETURNED FOR EVALUATION. LEG IS BENT WITH ONE LEG HIGHER THAN THE OTHER WHICH PULLS THE LEG INWARD MAKING THE NLYON ROLLER RIDE ON THE EDGE OF THE CHANNEL AND/OR TRAVEL DOWN THE CHANNEL AT AN ANGLE CREATING A WEAR SPOT ON THE ROLLER. LEG COULD BE BENT DUE TO POSSIBLE OVERLOADING OR HANGING UP ON SOMETHING SUCH AS A WINDOWSILL, FURNITURE IN THE ROOM, VISITOR SITTING ON THE BED, LOWERING BED DOWN ON SOMETHING UNDER THE BED, USING A LIFT THAT DID NOT OFFER ENOUGH CLEARANCE AND HITTING THE LEG, ETC. CAUSING THE LEG TO BEND. LEG HAD MARKS ON THE INSIDE AND OUTSIDE EDGE UNDER THE LEGS INDICATING IT HAD BEEN POSSIBLY BEEN HIT FROM THE SIDE, RUBBED OR SCUFFED UNDERNEATH OR FELL ONTO SOMETHING THAT WAS UNDER THE BED. PREVIOUS TESTING FOUND THE ONLY WAY WE COULD RECREATE THE LEG COMING OUT OF THE CHANNEL WAS IF THE BED WAS LOADED WITH MAXIMUM WEIGHT, HAD A BENT ARM AND BENT LEG AND IT WAS PREVENTED FROM MOVING UP AND THE UP BUTTON CONTINUED TO BE PRESSED THUS BENDING THE LEG AND FORCING IT OUT OF THE CHANNEL. REPORT FILED 2/14/25, FOUND ON 3/27/25 DURING FOLLOW UP REPORTING THAT THE ORIGINAL REPORT WAS NOT RECIEVED. THIS REPORT ENCOMPASSES THE INITAL AND FOLLOW UP REPORT.