MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-03-10 for DISCOVERY DISCOVERY A manufactured by Hologic, Inc..
[17868883]
Customer called to report that the unit is making clicking noise and that the x-ray light stays on after the scan has ended. There was no injury to pt or to the operator reported.
Patient Sequence No: 1, Text Type: D, B5
[17910220]
After the report, the customer was instructed to remove the unit from use and service engineer was dispatched to perform evaluation and repair of the unit. The engineer confirmed the failure, determined that the failure was caused by a defective printed circuit board. The field engineer replaced the board and verified proper operation of the device. Once the unit was repaired it was returned to customer was use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221300-2009-00001 |
| MDR Report Key | 1377750 |
| Report Source | 05 |
| Date Received | 2009-03-10 |
| Date of Report | 2009-03-06 |
| Date of Event | 2009-02-11 |
| Date Mfgr Received | 2008-02-11 |
| Date Added to Maude | 2009-09-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LIDA REED, DIRECTOR |
| Manufacturer Street | 35 CROSBY DR. |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 7819997589 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISCOVERY |
| Generic Name | BONE DENSITY |
| Product Code | KGI |
| Date Received | 2009-03-10 |
| Model Number | DISCOVERY A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | BEDFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-10 |