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 2020-03-05 for GOLVO 9000 LOWBASE 2000049 manufactured by Liko Ab.
[182939517]
The hillrom technician found both left rear and front wheel caster broke and need replaced. The periodic inspection manual for liko mobile lifts (3en371001-rev 5) states under check point 3 "castors-wheels": roll the lift along the floor. Check to ensure that all wheels roll and turn freely. Make sure the wheels are fastened. Lock the brakes, make sure the wheels do not turn and the housing does not swivel when the lift is pushed. There should not be any play between the fork and the wheel nut. 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 front and rear wheels on left side of lift. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[182939518]
Hillrom received a report from the account stating the front casters on the left side came off. 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 | 8030916-2020-00009 |
| MDR Report Key | 9793117 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-05 |
| 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 | GOLVO 9000 LOWBASE |
| Generic Name | NON-AC POWERED PATIENT LIFT |
| Product Code | FSA |
| Date Received | 2020-03-05 |
| Model Number | 2000049 |
| 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 | 1. Required No Informationntervention | 2020-03-05 |