MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-05-06 for MDS808200WX manufactured by Medline Industries, Inc..
[44663311]
The end user's daughter reported that while pushing on the handles to clear a curb, the left latch released and the end user fell out of the transport chair on to the ground. Her doctor diagnosed a rib fracture but it is unknown if any x-rays were done to confirm that diagnosis. The end user's daughter stated that she had tightened the release pin for the left push handle prior to this incident. The sample has been returned for evaluation. It was confirmed that an adjustment was made to the release pin for the left push handle. The release pin was not protruding enough to lock the handle into place. When adjusted correctly, the left handle securely locked into place. It is unknown if the seat belt was applied as recommended in the owner's manual. The owner's manual also states not to attempt to ride over curbs or obstacles. Doing so may cause your chair to tip over. The owner's manual further states to make sure that the seatback is locked in the upright position. We have determined that the most likely root cause for this incident to be user error.
Patient Sequence No: 1, Text Type: N, H10
[44663312]
The end user's daughter reported that while pushing on the handles to clear a curb, the left latch released and the end user fell out of the transport chair on to the ground and suffered a rib fracture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00056 |
| MDR Report Key | 5637598 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-05-06 |
| Date of Report | 2016-05-06 |
| Date of Event | 2016-03-23 |
| Date Mfgr Received | 2016-04-11 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2016-05-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2016-05-06 |
| Catalog Number | MDS808200WX |
| Lot Number | U140607371 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-05-06 |