FDA Adverse Event
Malfunction
Summary report: N
SOMATOM DEFINITION FLASH
MDR report key: 3880489
·
Received May 7, 2014
Report
- Report Number
- 2240869-2014-03364
- Event Type
- Malfunction
- Date Received
- May 7, 2014
- Date of Event
- April 8, 2014
- Report Date
- April 11, 2014
- Manufacturer
- SIEMENS AG MEDICAL SOLUTIONS
- Product Code
- JAK
- PMA / PMN Number
- K121072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
SIEMENS WAS NOTIFIED OF THE REPORTED ISSUE ON (B)(4)/2014. THIS MDR IS BEING MAILED ON (B)(4) 2014. THE INVESTIGATION IS ON-GOING AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.
Description of Event or Problem · 1
SIEMENS WAS INFORMED ON (B)(4) 2014 THAT PATIENTS HAVE BEEN EXPOSED TO HIGHER RADIATION DOSES THAN NECESSARY DUE TO ECG SIGNAL DISTURBANCES IN A NEWER VERSION OF A PT MONITORING MODULE (PMM2). REPORTEDLY, THE PMM2 HAS BEEN REPLACED WITH AN OLDER VERSION, PMM0 AND THE SYSTEM IS NOW OPERATING AS EXPECTED. THERE IS NO REPORT OF PT INJURY. THIS REPORTED ISSUE OCCURRED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 275565 | SOMATOM DEFINITION FLASH | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | JAK | SIEMENS AG MEDICAL SOLUTIONS | 10430603 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SW VERSION VA44A_SP2A| PATIENT MONITORING MODULE (PMM2) |