MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-05 for UNO 102 EE 2010004 manufactured by Liko Ab.
[182941111]
The hillrom technician found the emergency switch was broken. Per the periodic inspection for liko mobile lifts (3en371001 rev. 4) section 10 instructs: press the emergency stop button. With the emergency stop button in, verify the lift does not operate with the hand control buttons. Turn the red emergency button in the direction of the arrows. Verify the button releases from the locked position into the raised, open position. A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this lift. It is unknown if the facility performs preventative maintenance on their lift. The technician replaced the control box to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[182941112]
Hillrom received a report from the account stating the emergency switch was broken. The lift was located at the account. 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 | 8030916-2020-00006 |
| MDR Report Key | 9673479 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-01-14 |
| Date Added to Maude | 2020-02-05 |
| 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 | UNO 102 EE |
| Generic Name | NON-AC POWERED PATIENT LIFT |
| Product Code | FSA |
| Date Received | 2020-02-05 |
| Model Number | 2010004 |
| 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] SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |