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..
[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
| Report Number | 3006984916-2012-00002 |
| MDR Report Key | 2774011 |
| Report Source | 08 |
| Date Received | 2012-09-27 |
| Date of Report | 2012-08-30 |
| Date of Event | 2012-07-18 |
| Date Mfgr Received | 2012-08-30 |
| Device Manufacturer Date | 2010-09-01 |
| Date Added to Maude | 2012-10-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN ZU |
| Manufacturer City | BOLUO HSIUNG, HUIZHOU CITY, GUANGDONG |
| Manufacturer Country | CH |
| Manufacturer Phone | 26865366 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE MEDICAL |
| Generic Name | BED RAIL |
| Product Code | INB |
| Date Received | 2012-09-27 |
| Model Number | 15201BV |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FORT METAL PLASTIC CO. LTD. |
| Manufacturer Address | GUANGDONG CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2012-09-27 |