MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-07 for DRIVE MEDICAL 13245 manufactured by Apex Healthcare Mfg., Inc..
[61697830]
(b)(4) received notice about this claim from (b)(6) (nursing home), involving a patient lift, a product imported and distributed by (b)(4). While the enduser was being transferred from the wheelchair to the bed, the lift allegedly made a popping noise before the loop from the sling slid off the lift cradle causing the enduser to fall to the floor. The enduser fractured his t9 vertebrae in his back. This report is based on the information that was provided by (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2016-00061 |
| MDR Report Key | 6153203 |
| Date Received | 2016-12-07 |
| Date of Report | 2016-11-09 |
| Date of Event | 2016-11-04 |
| Date Facility Aware | 2016-11-09 |
| Report Date | 2016-12-07 |
| Date Reported to FDA | 2016-12-07 |
| Date Reported to Mfgr | 2016-12-07 |
| Date Added to Maude | 2016-12-07 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | DRIVE MEDICAL |
| Generic Name | LIFT, PATIENT, AC-POWERED |
| Product Code | FNG |
| Date Received | 2016-12-07 |
| Model Number | 13245 |
| Operator | NURSING ASSISTANT |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APEX HEALTHCARE MFG., INC. |
| Manufacturer Address | NO. 6, INDUSTRIAL 2ND RD TOU CHIAO INDUSTRIAL PARK MIN HSIUNG CHIAYI, TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-07 |