FDA Adverse Event
Malfunction
Summary report: N
BV PULSERA
MDR report key: 1586283
·
Received January 8, 2010
Report
- Report Number
- 3003768277-2010-00001
- Event Type
- Malfunction
- Date Received
- January 8, 2010
- Date of Event
- December 16, 2009
- Report Date
- December 16, 2009
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- IZL
- PMA / PMN Number
- K010435
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR X-RAY MFR IN (B)(4), TO SUBMIT THIS EVENT. PROBLEM: THIS X-RAY UNIT FAILED TO IMAGE AFTER MAKING A LATERAL RUN DURING A POSTOPERATIVE AVM INTRAOPERATIVE LEFT INTERNAL CAROTID ARTERY STUDY. THE UNIT WOULD NOT INITIALIZE AFTER SEVERAL ATTEMPTS BY THE TECHNICIANS. THEREFORE, IT WAS DECIDED TO WITHDRAW THE CATHETER RATHER THAN LEAVE IT IN THAT LOCATION FOR TOO LONG. THE PT WAS REMOVED FROM THE TABLE. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BV PULSERA | IZL ( MOBILE X-RAY SYSTEM) | IZL | PHILIPS MEDICAL SYSTEMS | 718095 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |