DRIVE MEDICAL 15201BV NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-09-27 for DRIVE MEDICAL 15201BV NA manufactured by Fort Metal Plastic Co. Ltd..

Event Text Entries

[20418526] Fort has received a report of adverse event from drive medical, one of our distributors in the us. It was alleged that a hospice patient was given medications at 7:30 am of the date of event while he was in the bed, and allegedly at 11 pm he was found deceased in a position of kneeling next to the bed, with his head between the bed rail and mattress. According to information his daughter received from the coroner, that the cause of death was allegedly suffocation. Among other concomitant medical devices, the alleged bed rail was originally manufactured by fort and imported to the us by (b)(4). This mdr report is based on the information provided by the assisted living facility, the hospice company and (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[20537447] Since there is no report of defect in the alleged rail, and the alleged rail was not returned to fort, we are unable to evaluate it and determine the root cause of the adverse event. However, we have re-conducted an assessment on all the seven (7) zones recommended by the fda on this model of bed rail. The assessment was conducted according to the fda guidance titled "hospital bed system dimensional and assessment guidance to reduce bed system dimensional and assessment guidance to reduce entrapment" issued on march 10, 2006. Fot has concluded that except zone 7, which does not apply to a bed rail, all other six (6) zones were evaluated and considered to be in compliance with the fda guidance. Manufacturers for concomitant medical products: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3006984916-2012-00002
MDR Report Key2774011
Report Source08
Date Received2012-09-27
Date of Report2012-08-30
Date of Event2012-07-18
Date Mfgr Received2012-08-30
Device Manufacturer Date2010-09-01
Date Added to Maude2012-10-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJOHN ZU
Manufacturer CityBOLUO HSIUNG, HUIZHOU CITY, GUANGDONG
Manufacturer CountryCH
Manufacturer Phone26865366
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDRIVE MEDICAL
Generic NameBED RAIL
Product CodeINB
Date Received2012-09-27
Model Number15201BV
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerFORT METAL PLASTIC CO. LTD.
Manufacturer AddressGUANGDONG CH


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2012-09-27

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