MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-26 for GOLVO 8008 manufactured by Liko (hill-rom Inc.).
[87344046]
Patient Sequence No: 1, Text Type: N, H10
[87344047]
Nurse started to raise the patient with a liko golvo 8008 lift, and as the patient was suspended above right side of bed the equipment stopped lifting and began to tilt forward, raising the back of the lift. The nurse gently guided the patient a bit diagonally down into their bed. Apparently this motion caused an employee injury. The original call was placed to biomed as the machine malfunctioned and our biomeds completed a full preventative maintenance on the unit and everything was working as designed. The battery seems a bit weak, so our tech purchased one and replaced it. The unit was taken right back to service. Due to the fact that the employee injury was brought up at a later date we had a liko rep come out and check out the unit. This was the sales person, who also teaches staff how to use the equipment. After 3 days of being on site this was deemed a user error as the rep found the lifting strap wrinkled which means that someone had continuously pulled on the strap at an angle and the strap had bunched up inside the opening on several occasion, this could make the unit stop lifting. The rep did some retraining on usage and the unit has been back in service since without failure. Manufacturer response for patient lift, golvo 8008 (per site reporter): they came out, tested operation, deemed user error, and did some retraining.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6893674 |
| MDR Report Key | 6893674 |
| Date Received | 2017-09-26 |
| Date of Report | 2017-09-20 |
| Date of Event | 2017-05-08 |
| Report Date | 2017-09-20 |
| Date Reported to FDA | 2017-09-20 |
| Date Reported to Mfgr | 2017-09-20 |
| Date Added to Maude | 2017-09-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOLVO |
| Generic Name | LIFT, PATIENT, AC-POWERED |
| Product Code | FNG |
| Date Received | 2017-09-26 |
| Model Number | 8008 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIKO (HILL-ROM INC.) |
| Manufacturer Address | 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-26 |