MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-21 for MDS6800BAH manufactured by Medline Industries Inc..
[180391276]
It was reported that a (b)(6) old ,female living in a senior living facility was found deceased after falling off of her bed. On (b)(6) 2019 the patient was found with her neck resting across a bar of a bedside handrail designed to assist an individual to get in and out of bed. The incident report indicated the victim had rolled over while sleeping and fell off of the bed. According to the incident report, the twin size mattress had shifted off center in relationship to the bed spring and the handrail was not fastened to the bed. This created a gap between the handrail and mattress. Examination of the handrail by the police determined that there was no safety strap attached to the handrail. Also, the legs of the handrail were not fully extended to the floor. No additional information was reported to the manufacturer. No sample was returned to the manufacturer for evaluation. A root cause for the reported incident could not be determined. Due to the reported death, and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed
Patient Sequence No: 1, Text Type: N, H10
[180391277]
It was reported that the end-user caught her neck in the bed assist bar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2020-00017 |
| MDR Report Key | 9739650 |
| Report Source | OTHER |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2019-07-31 |
| Date Mfgr Received | 2020-02-05 |
| Date Added to Maude | 2020-02-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 6434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | BED ASSIST RAIL |
| Product Code | IKX |
| Date Received | 2020-02-21 |
| Catalog Number | MDS6800BAH |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-21 |