MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-01 for FREECURVE manufactured by Handicare Stairlifts B.v.
[125905180]
Retrospective medical device reporting.
Patient Sequence No: 1, Text Type: N, H10
[125905181]
Lift tilted sideways. Outgoing shaft could slip in the last gear in the gearbox. Investigation showed that where normally the pinion is pushed on the shaft, creating dents and a form fit, this was not the case in this gearbox. Most probably; therefore, the tolerances of the inner hole in the last gear were out of specification. Drawings are owned by (b)(4); supplier of the particular faulty gearbox. We requested feedback from (b)(4) multiple times regarding root cause analysis but so far handicare has received none.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007802293-2018-00044 |
| MDR Report Key | 8030721 |
| Date Received | 2018-11-01 |
| Date of Report | 2018-11-01 |
| Date of Event | 2017-11-09 |
| Date Facility Aware | 2018-11-01 |
| Date Added to Maude | 2018-11-01 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREECURVE |
| Generic Name | STAIRLIFTS |
| Product Code | PCD |
| Date Received | 2018-11-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-11-01 |