DIV30 DME - MISCELLANEOUS
Received Jun 9, 2026 · Event occurred Aug 15, 2023
Report 1417592-2026-02236 · MDR key 25444737
Device
Product problems
- Insufficient Device Problem Information
Patient
NA · Female
- Dehydration
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
DECEDENT WAS FOUND ON HER BEDROOM FLOOR WITH HER ARM TRAPPED BETWEEN THE BED RAIL AND MATTRESS.
Additional Manufacturer Narrative
IT WAS REPORTED THAT DECEDENT WAS FOUND ON HER BEDROOM FLOOR WITH HER ARM TRAPPED BETWEEN THE BED RAIL AND MATTRESS AND REMAINED TRAPPED FOR 12 HOURS, UNABLE TO MOVE. IT WAS REPORTED THAT RESPONDERS WERE "REQUIRED TO PARTIALLY DISASSEMBLE THE BED TO FREE THE DECEDENT". DUE TO THIS, THE USER "SUFFERED SEVERE DEHYDRATION, TRAUMATIC INJURIES, AND RHABDOMYOLYSIS". IT WAS REPORTED THAT THE STRESS "CAUSED DECEDENT TO SUFFER CARDIAC ARREST WHILE RECEIVING EMERGENCY TREATMENT". DECEDENT REMAINED "HOSPITALIZED, SEDATED, AND INTUBATED UNTIL HER DEATH". IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.