MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-12-10 for DISCOVERY DISCOVERY-CI manufactured by Hologic, Inc..
[17719245]
Customer called to report that x-rays are not shutting off after qc is done and also after some patient scans. Customer reported that she could hear the audible hum produced by the high voltage transformer. She reset the system and the problem went away. The fact that the x-rays were on was not supported by an actual measurement. There were no injury to any patient reported.
Patient Sequence No: 1, Text Type: D, B5
[18010843]
The unit was removed from service and service engineer was dispatched to perform evaluation and repair of the unit. The field engineer was unable to confirm the failure of the x-ray to shut off. Since the customer reported other errors as well, the field engineer replaced several components and verified proper operation of the device. After several weeks, radiation safety officer contacted the customer to confirm proper operation of the device. The customer reported that she no longer experiences the problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221300-2008-00006 |
| MDR Report Key | 1305565 |
| Report Source | 05 |
| Date Received | 2008-12-10 |
| Date of Report | 2008-12-09 |
| Date of Event | 2008-10-13 |
| Date Mfgr Received | 2008-10-13 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2009-11-09 |
| 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 | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISCOVERY |
| Generic Name | BONE DENSITY |
| Product Code | KGI |
| Date Received | 2008-12-10 |
| Model Number | DISCOVERY-CI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | BEDFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-12-10 |