FDA Adverse Event
Malfunction
Summary report: N
INTEGRIS H3000
MDR report key: 1942848
·
Received December 21, 2010
Report
- Report Number
- 3003768277-2010-00380
- Event Type
- Malfunction
- Date Received
- December 21, 2010
- Date of Event
- November 25, 2010
- Report Date
- November 25, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- IZI
- PMA / PMN Number
- K925302
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(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 CUSTOMER REPORTED THAT THE SYSTEM FAILED TWICE DURING A PATIENT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRIS H3000 | IZI SYSTEM, X-RAY, ANGIOGRAPHIC | IZI | PHILIPS MEDICAL SYSTEMS | 72238 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |