FDA Adverse Event Death Summary report: N

DRIVE

MDR report key: 13649139 · Received March 2, 2022

Report

Report Number
3014644996-2022-00005
Event Type
Death
Date Received
March 2, 2022
Date of Event
June 28, 2020
Report Date
March 2, 2022
Manufacturer
COM-DA HEALTHCARE CO.,LTD
Product Code
IKZ
UDI-DI
00822383143026
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 0

FROM DRIVE DEVILBISS: DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BED RAIL. THE INCIDENT WAS REPORTED TO CPSC. WE ARE FILING THIS REPORT PRIOR TO COMPLETION OF OUR INVESTIGATION.. THE REPORT WILL BE AMENDED WHEN ADDITIONAL INFORMATION IS ACQUIRED. THE END-USER WAS IN HOSPICE CARE. HIS EQUIPMENT WAS CHANGED WITHIN THE LAST TWO (2) WEEKS OF HIS LIFE INCLUDING HIS BED RAIL, LOW AIR LOSS MATTRESS AND HOSPITAL BED. THE FACILITY WAS INDEPENDENT LIVING, ADVANCED CARE HOME. HE WAS PLACED ON A TWO(2) HOUR WATCH SINCE HE HAD BEEN TRYING TO EXIT THE BED TO GET A DRINK. A CARE WORKER FOUND HIM TRAPPED UNDER THE BED RAIL WITH HIS FEET RESTING ON THE GROUND. HE DIED OF ACCIDENTAL, MECHANICAL ASPHYXIATION. THE NURSE ON STAFF THAT EVENING IS NO LONGER AN EMPLOYEE OF THE HOSPICE AND IS THEREFORE UNAVAILABLE FOR COMMENT. THE HOSPITAL SUPERVISOR REPORTED THAT THE DEVICES WERE RETURNED TO THE SERVICE PROVIDER AFTER THE INCIDENT. SHE ADVISED THAT THERE WERE NO ISSUES OR CONCERNS WITH THE RAILS, MATTRESSES, AND HOSPITAL BED. THERE WAS NO INVESTIGATION OF THE PRODUCTS AT THE HOSPICE LEVEL, DRIVE HAS UNABLE TO INDEPENDENTLY VERIFY THE CONFIGURATION OF THE PRODUCTS SINCE THEY WERE DISASSEMBLED AND RETURNED TO THE PROVIDER BEFORE DRIVE WAS NOTIFIED OF THE INCIDENT.. THE PRODUCT HAS BEEN UNAVAILABLE FOR EVALUATION. ROOT CAUSE HAS NOT BEEN DETERMINED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
339941 DRIVE BED RAIL IKZ COM-DA HEALTHCARE CO.,LTD 15201ABV 00822383143026

Patients

Seq Age Sex Outcome Treatment
1 98 YR Male Death