FDA Adverse Event
Malfunction
Summary report: N
SOMATOM PLUS 4 POWER
MDR report key: 329004
·
Received April 23, 2001
Report
- Report Number
- 2240869-2001-00006
- Event Type
- Malfunction
- Date Received
- April 23, 2001
- Date of Event
- March 15, 2001
- Report Date
- March 22, 2001
- Manufacturer
- SIEMENS MEDICAL SYSTEMS, INC.
- Product Code
- JAK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CO WAS INFORMED THAT A PT WITH ID = "A" HAD BEEN REGISTERED FOR AN EXAMINATION. AFTERWARDS DATA FROM ANOTHER PT WITH ID = "B" HAD BEEN REQUESTED AND RECONSTRUCTED. THEN THE FIRST REGISTERED PT WITH ID = "A" WAS SCANNED AND PT'S IMAGES RECONSTRUCTED. NOW IT WAS NOTICED THAT BOTH PTS WERE LABELED WITH ID = "B".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18560 | SOMATOM PLUS 4 POWER | COMPUTED TOMOGRAPHY | JAK | SIEMENS MEDICAL SYSTEMS, INC. | 2216919 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |