MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-09 for FETAL DOPPLER JPD-100B manufactured by Shenzhen Jumper Medical Equipm.
[22138985]
I bought a fetal doppler and found that this device is not approved by fda. The (b)(6) seller is (b)(6). The brand is jumper. Model: jpd 100b. I searched it on www. Fda. Org and cannot find this brand device too. The (b)(6) item number is: the listing is (b)(6). Please check it. If it is not fda approved, please stop this violation which may hurt the mom and the baby.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5031777 |
| MDR Report Key | 3345651 |
| Date Received | 2013-09-09 |
| Date of Report | 2013-09-06 |
| Date of Event | 2013-08-30 |
| Date Added to Maude | 2013-09-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FETAL DOPPLER |
| Generic Name | FETAL DOPPLER |
| Product Code | KNG |
| Date Received | 2013-09-09 |
| Model Number | JPD-100B |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN JUMPER MEDICAL EQUIPM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-09 |