MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-18 for PROBASICS WC41816DS manufactured by Sichuan Ast Medical Equipment Co., Ltd..
[130773327]
User went to get out of wheelchair to move to the toilet, and the chair moved because the left brake no longer works - she fell and was knocked out. She went to the doctor the next day with her caregiver and was told she had a concussion. The user called back to state that she went to the er and had to take an x-ray. The doctor looked at her swiftly and said she had a concussion, but that's it. No tests or direction what to do about it. States that she was sitting on her toilet seat, and her toilet seat snapped, and she went to go grab the wheelchair to catch herself, but it moved because the left brake does not work, and she fell and lost consciousness for maybe 10-15 minutes. She had her phone and called someone to come help her up back in her wheelchair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2018-00061 |
| MDR Report Key | 8176285 |
| Date Received | 2018-12-18 |
| Date of Report | 2019-02-13 |
| Date Facility Aware | 2018-11-29 |
| Report Date | 2019-02-13 |
| Date Reported to FDA | 2019-02-13 |
| Date Reported to Mfgr | 2019-02-13 |
| Date Added to Maude | 2018-12-18 |
| 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 | PROBASICS |
| Generic Name | WHEELCHAIR |
| Product Code | KNN |
| Date Received | 2018-12-18 |
| Model Number | WC41816DS |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SICHUAN AST MEDICAL EQUIPMENT CO., LTD. |
| Manufacturer Address | NO. 58, JIN-PENG ROAD C AREA, LUXIAN INDUSTRIAL PARK LUZHOU CITY SICHUAN, CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-12-18 |