FDA Adverse Event
Malfunction
Summary report: N
ASSY, AMI 9700 CONSOLE
MDR report key: 3072549
·
Received April 18, 2013
Report
- Report Number
- 3022472-2013-00073
- Event Type
- Malfunction
- Date Received
- April 18, 2013
- Date of Event
- March 22, 2013
- Report Date
- March 22, 2013
- Manufacturer
- VERATHON MEDICAL
- Product Code
- IYO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED EVENT ALLEGES A MALFUNCTION OF A POTENTIAL INACCURACY. VERATHON WILL CONTINUE THE INVESTIGATION PENDING RETURN AND ANALYSIS OF THE PRODUCT.
Description of Event or Problem · 1
USING AN AORTASCAN - ABDOMINAL AORTIC ULTRASOUND, A DOCTOR, AS WELL AS A VERATHON REP, SCANNED A PT WITH A KNOWN ABDOMINAL AORTIC ANEURYSM (AAA). THE RESULT OF THE SCAN DID NOT CORRELATE WITH THE KNOWN AAA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 168571 | ASSY, AMI 9700 CONSOLE | NONE | IYO | VERATHON MEDICAL | 0570-0303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SN# (B)(4), MFG DATE 01/2013.| ASSY PROBE AMI 9700: PART # 0570-0309, |