MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-04-27 for MDS808200SLRR manufactured by Medline Industries, Inc..
[43763642]
The facility reported that the transport chair fell backwards when a patient sat in it. The patient was treated for an injury and released from the er. The reported injury and treatment is unknown. It is unknown if the brakes were engaged. It is unknown if there were anti-tippers on the transport chair. The sample was not returned for evaluation and a root cause has not been determined. The owner's manual addresses center of gravity, balance and stability. It indicates that the center of gravity must be maintained and that the loss of proper balance may cause the transport chair to tip over. The transport chair manual also states that it is recommended to use with an anti-tip device. We cannot rule out user error as a potential root cause. Due to the reported injury and in an abundance of caution, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[43763643]
The facility reported that the transport chair fell backwards and the patient was treated and released.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00047 |
| MDR Report Key | 5610928 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-04-27 |
| Date of Report | 2016-04-27 |
| Date of Event | 2016-03-29 |
| Date Mfgr Received | 2016-03-29 |
| Date Added to Maude | 2016-04-27 |
| 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 | 2016-04-27 |
| Catalog Number | MDS808200SLRR |
| Lot Number | UNK |
| 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 | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-27 |