FDA Adverse Event
Malfunction
Summary report: N
INTEGRIS HM3000
MDR report key: 1942667
·
Received December 8, 2010
Report
- Report Number
- 3003768277-2010-00356
- Event Type
- Malfunction
- Date Received
- December 8, 2010
- Date of Event
- August 10, 2010
- Report Date
- August 10, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- IZF
- PMA / PMN Number
- K925302
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL METHOD, RESULTS, CONCLUSIONS - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
THE SITE REPORTED AN ELEVATED FLUORO DOSE FROM THIS X-RAY SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRIS HM3000 | IZF (SYSTEM, X-RAY, TOMOGRAPHIC) | IZF | PHILIPS MEDICAL SYSTEMS | 72239 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |