MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-28 for DOPPLER PROBE manufactured by .
[96124356]
On 11/3/2017 koven received the medwatch form in the mail. On 11/3/2017 phone call to initial reporter, no answer, no voice mail. On 11/6/2017 emailed initial reporter to contact koven right away. On 11/7/2017 hospital contacted koven and koven requested the probe be returned for evaluation and replaced probe at no charge. Investigation was completed on the probe and it was found to be working properly. No issues were found with the probe. No way of uncovering why it did not work at the hospital site.
Patient Sequence No: 1, Text Type: N, H10
[96124357]
Hospital said they plugged in the probe and it did not work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001937397-0001-01117 |
| MDR Report Key | 7151649 |
| Date Received | 2017-12-28 |
| Date of Report | 2017-11-30 |
| Date of Event | 2017-09-07 |
| Date Facility Aware | 2017-11-03 |
| Date Added to Maude | 2017-12-28 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | DOPPLER PROBE |
| Product Code | JOP |
| Date Received | 2017-12-28 |
| Device Availability | * |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer Address | MO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-28 |