MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-01-10 for HORIZON HORIZON-CI N/A manufactured by Hologic, Inc..
[96949625]
It was reported that they were getting errors during a scan, causing the patient to be re-exposed. It was determined that recalibration of the filter drum was needed. Once this was done, the system is working as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2018-00052 |
| MDR Report Key | 7180393 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-10 |
| Date of Report | 2018-01-09 |
| Date of Event | 2017-09-15 |
| Date Mfgr Received | 2018-01-09 |
| Device Manufacturer Date | 2017-08-09 |
| Date Added to Maude | 2018-01-10 |
| 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 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| 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 |
| Manufacturer Phone | 2032074512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HORIZON |
| Generic Name | DENSITOMETER, BONE |
| Product Code | KGI |
| Date Received | 2018-01-10 |
| Model Number | HORIZON-CI |
| 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 | 2018-01-10 |