MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-06 for LIKORALL 250 ES, NATURAL 3122501 manufactured by Liko Ab.
[182940485]
The lift has been investigated by an hillrom technician and pictures of the broken plastic quick release has been investigated by engineers at the manufacturing site. The red plastic quick release is used only as a guide to see if the hook is positioned correctly, not to take any load of the patient. If it breaks during a lift, it is an indication that the hook is positioned in an incorrect way. In the user manual for the universal slingbars (7en160185 rev. 4) it is stated under care and maintenance it is stated: "for safe and trouble-free operation, a few routine procedures should be performed every day, before the sling bar is in use: when using a quick-release hook system, check that the quick-release hook is correctly fastened to the lift and the sling bar before lifting, check that the lifting accessory hangs vertically and can move freely" the customer has been informed that they need to replace the sling bar with the quick release hook and that they need to inspect the device on a regular basis. Based on this, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[182940486]
Hillrom received a report stating that the customer alleged that when trying to look at the weight while patient hang freely, the red plastic of the quick release hook was broken and the patient fell on the floor, patient got frightened but got away with a few scrapes. The lift is located at the account. There was no serious patient/user injury reported. This report was filed in our complaint system as (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030916-2020-00005 |
| MDR Report Key | 9679418 |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2010-02-08 |
| Date Added to Maude | 2020-02-06 |
| 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 | BETH GRACEFFA |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 3122337700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIKORALL 250 ES, NATURAL |
| Generic Name | NON-AC POWERED PATIENT LIFT |
| Product Code | FSA |
| Date Received | 2020-02-06 |
| Model Number | 3122501 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIKO AB |
| Manufacturer Address | NEDRE VAGEN 100 LULEA, NORRBOTTENS LAN [SE-25] 975 92 SW 975 92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |