MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-10-21 for DISCOVERY DISCOVERY C manufactured by Hologic, Inc..
[2340705]
Customer called to report that x-ray lights stays on after the scan is completed. No injury to patient or to the operator were reported.
Patient Sequence No: 1, Text Type: D, B5
[9425263]
When the report was received, the customer was instructed to remove the unit from service and field engineer was dispatched to perform evaluation and repair of the unit. The field engineer determined that the failure was caused by a defective c-arm interface board. The field engineer replaced the board and verified proper operation of the device. Follow up service was scheduled and upgrade of the software in accordance with the recall instructions was performed. The unit was then returned to service and is operating in accordance with the specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221300-2011-00001 |
| MDR Report Key | 2319606 |
| Report Source | 05 |
| Date Received | 2011-10-21 |
| Date of Report | 2011-10-22 |
| Date of Event | 2011-10-03 |
| Date Mfgr Received | 2011-10-03 |
| Device Manufacturer Date | 2007-03-01 |
| Date Added to Maude | 2012-07-09 |
| 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 | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1725-2009 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISCOVERY |
| Generic Name | BONE DENSITY |
| Product Code | KGI |
| Date Received | 2011-10-21 |
| Model Number | DISCOVERY C |
| 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. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-21 |