FDA Adverse Event Death Summary report: N

SPLIT RAIL BED SIDE RAIL

MDR report key: 1967 · Received December 3, 1992

Report

Report Number
1967
Event Type
Death
Date Received
December 3, 1992
Date of Event
July 14, 1992
Report Date
July 24, 1992
Manufacturer
HILL-ROM
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

THE INCIDENT IN QUESTION OCCURRED ON JULY 14, 1992 AT 11:05 P.M. WHEN PATIENT WAS FOUND BY THE ON-DUTY NURSE WITH HER FEET, LEGS AND BUTTOCKS ON THE FLOOR AND HER HEAD, SHOULDER, THROAT AND ONE ARM BETWEEN THE SIDE RAIL AND THE BED IN THE MIDDLE OF THE LEFT SIDE OF THE BED. WHEN DISCOVERED, THE PATIENT HAD NO VITAL SISGNS, SHE WAS STILL WARM TO THE TOUCH, HER SKIN WAS MILDLY WHITE AND THERE WAS NO PETECHIAE OR BLOATING OF THE FACE. SOME BRUISING OF THE NECK AND CHEST WERE EVIDENT. WE HAVE REQUESTED THE COUNTY CORONER'S OFFICER TO INVESTIGATE THE INCIDENT AND TO DATE HAVE NOT RECEIVED A REPORT. WE HAVE DISCONTINUED THE USE OF THIS MODEL SIDE RAILS FOR RESIDENTS WITH SIDE RAIL RESTRAINT ORDERS AND HAVE SWITCHED TO FULL RAIL SETS. MANUFACTURER NOTIFIEDINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SPLIT RAIL BED SIDE RAIL BED/SIDE RAIL HILL-ROM 425

Patients

Seq Age Sex Outcome Treatment
1 72 YR Death