FDA Adverse Event
Malfunction
Summary report: N
BV PULSERA, REL. 2.3
MDR report key: 2036717
·
Received February 18, 2011
Report
- Report Number
- 3003768277-2011-00179
- Event Type
- Malfunction
- Date Received
- February 18, 2011
- Report Date
- January 24, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IZL
- PMA / PMN Number
- K010435
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA BY 04/22/2011.
Description of Event or Problem · 1
THE CUSTOMER REPORTED "CORRUPT IMAGES ON THE FLUORO IMAGE, HAD TO CHANGE OUT C-ARM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BV PULSERA, REL. 2.3 | IZL | PHILIPS HEALTHCARE | 718095 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |