FDA Adverse Event
Malfunction
Summary report: N
VPS CONSOLE (FLYBOOK) W/ACC (PS, 8FT CORD, EKG LD)
MDR report key: 3190552
·
Received June 21, 2013
Report
- Report Number
- 3006795936-2013-00015
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- May 28, 2013
- Report Date
- June 20, 2013
- Manufacturer
- VASONOVA
- Product Code
- OBJ
- PMA / PMN Number
- K103260
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED ON A (B)(6), IN THE OUTPATIENT FACILITY. DURING INSERTION INTO THE PT'S BRACHIAL VEIN, THE CONSOLE SHOWED A BLUE BULLSEYE FOR THE LAST 15CM OF INSERTION WITH ELEVATED P-WAVES AND A BEAUTIFUL DOPPLER. AS A RESULT, THE CLINICIAN SWITCHED ARMS AND ATTEMPTED ANOTHER INSERTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282722 | VPS CONSOLE (FLYBOOK) W/ACC (PS, 8FT CORD, EKG LD) | CATHETER, ULTRASOUND, INTRAVASCULAR | OBJ | VASONOVA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR |