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 2020-02-11 for SABINA II EE 2020003 manufactured by Liko Ab.
[182917739]
Hillrom technician visited the customer and concluded that the extension cable was broken. Hillrom engineers viewed a picture of the cable and were able to confirm the assessment of the technician. The picture shows a damage in the cable insulation. In the periodic inspection manual for liko mobile lifts (3en371001 rev. 4) it is stated under section 8: [check cables and connectors for damage or wear. In the instruction manual for sabina lifts (7en155106 rev 1) it is stated on page 3: before lifting, always make sure that: the lifting accessories are not damaged and on page 9: if the charger cable is beginning to stretch, it should be replaced in order to minimize the risk of the cable getting stuck and breaking. A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this lift in june 2019. It is unknown if the facility performed any other preventative maintenance on this lift. The technician replaced the extension cable to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[182917740]
Hillrom received a report from the account that alleged that the lift was about to be charged when the charger cable was attached to the power outlet there was a loud bang, a flash, and then a burning smell in which occurred on two different outlets with the same results. The device was located at the account at the time of the incident. There was no patient/user injury reported. This report was filed in our complaint handling system as (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030916-2020-00008 |
| MDR Report Key | 9695106 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2017-12-27 |
| Date Added to Maude | 2020-02-11 |
| 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 | SABINA II EE |
| Generic Name | NON-AC POWERED PATIENT LIFT |
| Product Code | FSA |
| Date Received | 2020-02-11 |
| Model Number | 2020003 |
| 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 | 2020-02-11 |