MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2015-06-19 for HOYER POWER LIFT 402 HPL402 manufactured by Apex Healthcare Mfg Inc.
[15383137]
It was reported to the mfr by the end user, per the end user during transfer from power wheelchair to dialysis recliner via electric hoyer lift, pt stated she was slipping out of her mesh sling. Staff member was positioned to pt's right side while pt was suspended above dialysis recliner in sling. Staff member was attempting to lower pt into chair using electronic hoyer remote as pt began to slide to floor. Staff member called for help was able to help maneuver pt to floor; however, pt's left leg became lodged beneath her body. Pt began complaining with leg pain. The pt was sent to the hosp for eval and testing. Pt sustained a fractured tibia, fibula, and femur of the left leg. Per the staff, the pt arrived at the clinic in her wheelchair with the sling beneath her. The clinic hooked the sling to the left and began the move to the recliner. The pt was known to rock and scoot around while in the sling. The sling model and mfr is unk. Complaint # (b)(4) was entered into our system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009402404-2015-00018 |
| MDR Report Key | 4860183 |
| Report Source | 06,08 |
| Date Received | 2015-06-19 |
| Date of Report | 2015-06-11 |
| Date of Event | 2015-06-01 |
| Date Facility Aware | 2015-06-01 |
| Report Date | 2015-06-18 |
| Date Reported to FDA | 2015-06-18 |
| Date Reported to Mfgr | 2015-06-18 |
| Date Mfgr Received | 2015-06-11 |
| Device Manufacturer Date | 2011-05-01 |
| Date Added to Maude | 2015-06-23 |
| 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 Street | 2100 DESIGN RD |
| Manufacturer City | ARLINGTON TX 760140000 |
| Manufacturer Country | US |
| Manufacturer Postal | 760140000 |
| Manufacturer Phone | 8008260270 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOYER POWER LIFT 402 |
| Generic Name | ELECTRIC PATIENT LIFTER |
| Product Code | FNG |
| Date Received | 2015-06-19 |
| Model Number | HPL402 |
| Catalog Number | HPL402 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APEX HEALTHCARE MFG INC |
| Manufacturer Address | MIN HSIUNG, CHI YI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-06-19 |