MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-12-14 for CITIA STAIRWAY CHAIRLIFT SL47 manufactured by Thyssenkrupp Access.
[2506508]
According to info received, (b)(6) and another person, were attempting to pick a pt up from the stairway chair lift in order to transfer her to a gurney/stretcher. During this time, mr. (b)(6) braced his right leg on the stairs next to the lift. The pt's nephew allegedly turned on the lift using the remote control and the lift movement pinned mr. (b)(6) leg between the lift and the stairs.
Patient Sequence No: 1, Text Type: D, B5
[9562086]
This form fda 3500a is being submitted to confirm that by letter of (b)(4), 2011, tk access provided a copy of a formal complaint regarding an incident with this medical device. At this time, tk access has not been given the opportunity to inspect the lift and for that reason has not been able to evaluated the claim that the lift malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1925312-2011-00001 |
| MDR Report Key | 2380852 |
| Report Source | 00 |
| Date Received | 2011-12-14 |
| Date of Report | 2011-12-13 |
| Date of Event | 2007-11-21 |
| Date Mfgr Received | 2011-03-31 |
| Date Added to Maude | 2012-07-24 |
| 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 | 4001 EAST 138TH ST. |
| Manufacturer City | GRANDVIEW MO 64030 |
| Manufacturer Country | US |
| Manufacturer Postal | 64030 |
| Manufacturer Phone | 8167675400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CITIA STAIRWAY CHAIRLIFT |
| Generic Name | POWERED PATIENT TRANSPORT 890.5150 |
| Product Code | ILK |
| Date Received | 2011-12-14 |
| Model Number | CITIA |
| Catalog Number | SL47 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THYSSENKRUPP ACCESS |
| Manufacturer Address | 4001 EAST 138TH ST. GRANDVIEW MO 64030 US 64030 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-14 |