FDA Adverse Event
Malfunction
Summary report: N
INTEGRIS H5000C
MDR report key: 1912426
·
Received November 15, 2010
Report
- Report Number
- 3003768277-2010-00291
- Event Type
- Malfunction
- Date Received
- November 15, 2010
- Date of Event
- November 3, 2010
- Report Date
- November 5, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- IZI
- PMA / PMN Number
- K984545
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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. (B)(4).
Description of Event or Problem · 1
THE EQUIPMENT WENT DOWN DURING AN INTERVENTION. THE SYS COULD NOT BE RESTARTED BY THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRIS H5000C | IZI (SYSTEM, X-RAY ANGIOGRAPHIC) | IZI | PHILIPS MEDICAL SYSTEMS | 722016 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |