FDA Adverse Event
Summary report: N
ARGUS GAMMA CAMERA
MDR report key: 1930015
·
Received December 14, 2010
Report
- Report Number
- 2916556-2010-00027
- Date Received
- December 14, 2010
- Report Date
- November 16, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
- Product Code
- KPS
- PMA / PMN Number
- K913471
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).
Description of Event or Problem · 1
A FIELD SERVICE ENGINEER AT THE CUSTOMER SITE HAS REPORTED A BROKEN WELD IN THE DETECTOR FORK ARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARGUS GAMMA CAMERA | KPS | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. | 2145-3007A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |