MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-09 for VARDLIFT 2300 V?RDLIFT 2300 manufactured by Liko Ab.
[40255015]
When the technician investigated the liko masterlift 2300, he found the lift strap axle was broken due to wear. A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this lift. It is unknown if the facility performs preventative maintenance on their lifts. Since the product is beyond its expected life, it will be scrapped. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[40255016]
Hill-rom received a report from the account stating that during a patient transfer, the lift strap from a liko masterlift 2300 released about 50-60 cm and the patient fell into the wheelchair. The lift was located in a patient room at the account at the time of the allegation. There was no patient/user injury reported. This report was filed in our complaint handling system as complaint #(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030916-2016-00033 |
| MDR Report Key | 5489815 |
| Date Received | 2016-03-09 |
| Date of Report | 2016-02-09 |
| Date of Event | 2016-02-09 |
| Date Mfgr Received | 2016-02-09 |
| Device Manufacturer Date | 1994-01-01 |
| Date Added to Maude | 2016-03-09 |
| 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 | MARLENE BJURMAN |
| Manufacturer Street | NEDRE V |
| Manufacturer City | LULE 975 92 |
| Manufacturer Country | SW |
| Manufacturer Postal | 975 92 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VARDLIFT 2300 |
| Generic Name | AC-POWERED PATIENT LIFT |
| Product Code | FNG |
| Date Received | 2016-03-09 |
| Model Number | V?RDLIFT 2300 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIKO AB |
| Manufacturer Address | NEDRE V?GEN 100 LULE?, NORRBOTTENS L?N 975 92 SW 975 92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-09 |