FDA Adverse Event
Malfunction
Summary report: N
SYSTEM, XRAY, MAMMOGRAPHIC
MDR report key: 1333717
·
Received January 22, 2009
Report
- Report Number
- 2240869-2009-00004
- Event Type
- Malfunction
- Date Received
- January 22, 2009
- Date of Event
- January 19, 2009
- Report Date
- January 21, 2009
- Manufacturer
- SIEMENS AG
- Product Code
- IZH
- PMA / PMN Number
- K042095
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RESULTS: BROKEN WELD. ADDITIONAL INFORMATION: ONLY THREE SYSTEMS ARE AFFECTED IN THE UNITED STATES. THE THREE AFFECTED SYSTEMS WILL BE REPAIRED AND RETURNED TO SERVICE BY: (B)(4).
Description of Event or Problem · 1
DURING ASSEMBLY OF A MAMMOTEST PRODUCTION UNIT, IT WAS DISCOVERED THAT THE PLATE WELDED TO THE INNER COLUMN MAY FAIL UNDER CERTAIN CONDITIONS DUE TO A MANUFACTURING FAULT. ACCORDING TO INFORMATION FROM THE SUPPLIER, THE TABLE WILL SHIFT DOWN 1.4 DEGREES OR A TOTAL OF 3.1 CM IF THIS FAILURE OCCURS. IF THE TABLE SHIFTS DOWN, THE LIMIT SWITCHES WILL ENGAGE AND THE TABLE WILL STOP ALL DOWNWARD MOTION. THIS WILL OCCUR BEFORE THE TABLE REACHES A MAXIMUM SHIFT FOR THE 1.4 DEGREES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM, XRAY, MAMMOGRAPHIC | MAMMOTEST | IZH | SIEMENS AG | 10144185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |