MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for DRIVE 12345 manufactured by Apex Health Care Mfg., Inc..
[184254700]
Drive devilbiss is the initial importer of the device which is a s patient lift. This report is in response to mw5091616. We are correcting inaccurate data in the report. Patient was in a lift sling when they moved to the right and fell. He was lethargic. He was taken to the emergency room for tests that were negative. No injury as a result of the fall. The lift is 6 years old. There is no deficiency in the lift or the sling. The mw report notes serious injury which is inaccurate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2020-00016 |
| MDR Report Key | 9759554 |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2019-12-02 |
| Date Facility Aware | 2020-02-01 |
| Report Date | 2020-02-26 |
| Date Reported to FDA | 2020-02-26 |
| Date Reported to Mfgr | 2020-02-27 |
| Date Added to Maude | 2020-02-26 |
| 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 |
| Generic Name | BARIATRIC PATIENT LIFT |
| Product Code | FSA |
| Date Received | 2020-02-26 |
| Model Number | 12345 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APEX HEALTH CARE MFG., INC. |
| Manufacturer Address | NO. 6, INDUSTRIAL 2ND ROAD TOU CHIAO INDUSTRIAL PARK, MIN HSIUNG SHIANG CHIAYI - DIS, TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |