MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-10-05 for DISCOVERY DISCOVERY A N/A manufactured by Hologic, Inc..
[88227511]
It was reported that the table was shutting down during scans causing the patient to be rescanned. It was found that they were frayed wires in the track shorting out the circuit boards. Once these were replaced the system is working as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2017-00056 |
| MDR Report Key | 6915269 |
| Report Source | USER FACILITY |
| Date Received | 2017-10-05 |
| Date of Report | 2017-09-06 |
| Date of Event | 2017-07-18 |
| Date Mfgr Received | 2017-09-06 |
| Device Manufacturer Date | 2008-01-03 |
| Date Added to Maude | 2017-10-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | DEBRA ROSENBERG |
| Manufacturer Street | 36 & 37 APPLE RIDGE ROAD |
| Manufacturer City | DANBURY CT 06810 |
| Manufacturer Country | US |
| Manufacturer Postal | 06810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISCOVERY |
| Generic Name | DENSITOMETER, BONE |
| Product Code | KGI |
| Date Received | 2017-10-05 |
| Model Number | DISCOVERY A |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | RADIOLOGIC TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 36 & 37 APPLE RIDGE ROAD DANBURY CT 06810 US 06810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-05 |