FDA Adverse Event
Malfunction
Summary report: N
INTEGRIS H5000C/ALLURA 9C
MDR report key: 2152568
·
Received June 27, 2011
Report
- Report Number
- 3003768277-2011-00426
- Event Type
- Malfunction
- Date Received
- June 27, 2011
- Report Date
- May 31, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IZI
- PMA / PMN Number
- K984545
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). WHEN INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT: "THE EQUIPMENT HAS FLUOROSCOPY MALFUNCTIONS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRIS H5000C/ALLURA 9C | IZI | PHILIPS HEALTHCARE | 722016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |