MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-02-17 for LEVANT STAIRWAY CHAIRLIFT manufactured by Thyssenkrupp Accessibility B.v..
[2389966]
According to info received, the user was being helped onto a powered pt transport at the top of a flight of stairs. Either the user or the helper failed to insure that the seat swivel mechanism was locked into place. The seat swiveled as the user was sitting down, causing her to lose her balance and fall down the stairs. The aide tried to prevent the fall, lost balance, and fell down the stairs.
Patient Sequence No: 1, Text Type: D, B5
[9654701]
User reportedly received stitches and was allowed to return home after medical examination. No info was available on any injuries to the aide.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006395295-2012-00001 |
| MDR Report Key | 2470923 |
| Report Source | 99 |
| Date Received | 2012-02-17 |
| Date of Report | 2012-02-17 |
| Date of Event | 2012-02-02 |
| Date Mfgr Received | 2012-02-02 |
| Device Manufacturer Date | 2011-05-24 |
| Date Added to Maude | 2012-07-31 |
| 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 Street | VAN UTRECHTWEG 99 KRIMPEN AAN DEN IJSSEL |
| Manufacturer City | ZUID-HOLLAND 2921LN |
| Manufacturer Country | NL |
| Manufacturer Postal | 2921 LN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVANT STAIRWAY CHAIRLIFT |
| Generic Name | POWERED PATIENT TRANSPORT 890.5150 |
| Product Code | ILK |
| Date Received | 2012-02-17 |
| Model Number | LEVANT |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THYSSENKRUPP ACCESSIBILITY B.V. |
| Manufacturer Address | VAN UTRECHTWEG 99 KRIMPEN AAN DEN IJSSEL ZUID-HOLLAND 2921LN NL 2921 LN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-17 |