MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-15 for HANDICARE STAIRLIFTS C0020090 manufactured by Handicare Stairlifts B.v.
[136596100]
Unit smoked from pcb on first run down could have been pinched wires from install. Should be inspected when returned. No injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013423626-2019-00007 |
| MDR Report Key | 8345344 |
| Date Received | 2019-02-15 |
| Date of Report | 2019-02-15 |
| Date of Event | 2019-01-17 |
| Date Facility Aware | 2019-01-17 |
| Date Mfgr Received | 2019-01-17 |
| Date Added to Maude | 2019-02-15 |
| 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 | JOHAN HUBERTS |
| Manufacturer Street | NEWTONSTRAAT 35 P.O. BOX 39 |
| Manufacturer City | HEERHUGOWAARD NOORD-HOLLAND, |
| Manufacturer Country | NL |
| Manufacturer G1 | HANDICARE STAIRLIFTS B.V |
| Manufacturer Street | NEWTONSTRAAT 35 P.O. BOX 39 |
| Manufacturer City | HEERHUGOWAARD, 1700AA |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 1700 AA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HANDICARE STAIRLIFTS |
| Generic Name | STAILIFTS |
| Product Code | PCD |
| Date Received | 2019-02-15 |
| Catalog Number | C0020090 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDICARE STAIRLIFTS B.V |
| Manufacturer Address | NEWTONSTRAAT 35 P.O. BOX 39 HEERHUGOWAARD, 1700AA NL 1700 AA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-15 |