MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-08-12 for MINILIFT200 401100334 manufactured by Handicare Ab.
[18365825]
A facility staff member was transferring the resident from a wheelchair to a bed using the mini lift 200. During the transfer, the lift tipped, the resident suffered a c-6 fracture and left hip fracture. A handicare rep visited the facility to assess the incident. After assessing the staff member's statement, an attempt was made to re-create the incident as described by the staff member. When the lift was positioned by the bed, the base of the lift was approximately 6-8" under the bed frame, making it impossible to tip from this position. The handicare rep then tried a 'worst case scenario', attempting to tip the lift away from the bed and with the castor's locked and was still unable to cause the unit to tip. It was noted that there was damage to the lift which was inconsistent with the incident described by the staff member operating the lift. The unit was fully inspected and tested by the handicare rep and deemed fit for use. Based on the info supplied, handicare feel that the incident occurred due to the equipment being used in a way not advised or described in the user manual. By following the directions in the user manual, the incident could not be re-created. Handicare's evaluation is improper use of equipment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005536958-2014-00009 |
| MDR Report Key | 4017670 |
| Report Source | 99 |
| Date Received | 2014-08-12 |
| Date of Report | 2014-07-18 |
| Date of Event | 2014-07-18 |
| Date Facility Aware | 2014-07-18 |
| Report Date | 2014-08-12 |
| Date Reported to FDA | 2014-08-12 |
| Date Reported to Mfgr | 2014-08-12 |
| Date Added to Maude | 2014-08-19 |
| 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 |
| Manufacturer Street | 344 NORTH READING RD. |
| Manufacturer City | EPHRATA PA 17522 |
| Manufacturer Country | US |
| Manufacturer Postal | 17522 |
| Manufacturer G1 | RISE LIFTS, INC. |
| Manufacturer Street | 344 NORTH READING RD. |
| Manufacturer City | EPHRATA PA 17522 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17522 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINILIFT200 |
| Product Code | FMR |
| Date Received | 2014-08-12 |
| Model Number | 200 |
| Catalog Number | 401100334 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDICARE AB |
| Manufacturer Address | BOX 640 JARFELLA 17527 SW 175 27 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-08-12 |