MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-02-25 for MDS808200SLRR manufactured by Medline Industries, Inc..
[39081077]
The son of the end user reported that his mother was a resident in a skilled nursing facility. While sitting in a transport chair, a nurse was attempting to lift his mother's legs onto a stool. The chair apparently tipped backwards and she fell, suffering multiple vertebral fractures. She subsequently died. We have limited information pertaining to this incident as the son indicated he received conflicting reports from the facility and the coroner. He stated that he evaluated the transport chair and could not find any evidence to suggest the device caused the incident. It is unknown if the brakes were engaged or if anyone was standing behind the transport chair to secure its position while the end user's legs were being lifted. The owner's manual addresses center of gravity, balance and stability. It indicates that the center of gravity must be maintained and that loss of proper balance may cause the transport chair to tip over. The sample has not been returned for evaluation and a root cause has not been determined. We have no information to suggest the existence of any manufacturing defect. We cannot rule out user error as a potential root cause. Due to the reported incident and in an abundance of caution, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[39081078]
The son of the end user reported that his mother was a resident in a skilled nursing facility. While sitting in a transport chair, a nurse was attempting to lift his mother's legs onto a stool. The chair apparently tipped backwards and she fell, suffering multiple vertebral fractures. She subsequently died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00013 |
| MDR Report Key | 5461346 |
| Report Source | CONSUMER |
| Date Received | 2016-02-25 |
| Date of Report | 2016-02-25 |
| Date of Event | 2016-01-26 |
| Date Mfgr Received | 2016-01-29 |
| Date Added to Maude | 2016-02-25 |
| 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 | DIANE CHRISTENSEN |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TRANSPORT CHAIR |
| Product Code | INM |
| Date Received | 2016-02-25 |
| Catalog Number | MDS808200SLRR |
| Lot Number | UNK |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2016-02-25 |