MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-24 for DRIVE SSP218DFA-SF manufactured by Jiangsu Jumao X-care Medical Equipment Co., Ltd.
[176296370]
Drive devilbiss healthcare is the initial importer of the device which is a wheelchair. The end-user's family is in possession of the wheelchair. It is not available for evaluation. The end-user's family member has advised that the end-user was being transported by a local transport company. The brakes of the chair were not locked. The wheelchair rolled down the ramp. The end-user fell and broke his femur. He reportedly died from the fall. The transport company is suggesting that the device was faulty. Date of death and medical information is not available due to hippa restrictions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2020-00005 |
| MDR Report Key | 9629000 |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-24 |
| Date of Event | 2019-10-20 |
| Date Facility Aware | 2020-01-23 |
| Report Date | 2020-01-24 |
| Date Reported to FDA | 2020-01-24 |
| Date Reported to Mfgr | 2020-01-27 |
| Date Added to Maude | 2020-01-24 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | WHEELCHAIR |
| Product Code | IOR |
| Date Received | 2020-01-24 |
| Model Number | SSP218DFA-SF |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD |
| Manufacturer Address | NO.36 DANYAN ROAD DANYANG JIANGSU, 212300 CH 212300 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2020-01-24 |