FDA Adverse Event
Malfunction
Summary report: N
ULTRASOUND CONSOLE ALPHA 5
MDR report key: 1019254
·
Received March 18, 2008
Report
- Report Number
- 1019254
- Event Type
- Malfunction
- Date Received
- March 18, 2008
- Date of Event
- February 5, 2008
- Report Date
- March 15, 2008
- Manufacturer
- ALOKA CO LTD
- Product Code
- ITX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
THE ALOKA ULTRASOUND MACHINE DID NOT WORK, DID NOT TURN ON. WE HAD TO THEN GET AN ULTRASOUND MACHINE FROM LABOR AND DELIVERY.THE ALOKA ULTRASOUND UNIT IS 3 MONTHS OLD. WE TELEPHONED THE SERVICE DEPARTMENT AND SPOKE WITH A SERVICE REPRESENTATIVE WHO STATED THAT THE SSD ALPHA5 HAS BEEN MANUFACTURED AND MARKETED FOR 5 YEARS, AND NO OTHER SIMILAR PROBLEM HAS BEEN REPORTED. THE SERVICE REP, SUGGESTED TRAINING STAFF ON EMERGENCY SWITCH LOCATION AND PRECAUTION; HOWEVER, HE ALSO RECOMMENDED THAT WE CONTACT QUALITY ASSURANCE AND REPORT THE PROBLEM.ALOKA IS MANUFACTURED, AND THE HEADQUARTERS IS LOCATED IN TOKYO JAPAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRASOUND CONSOLE ALPHA 5 | ULTRASOUND MACHINE | ITX | ALOKA CO LTD | SSDALPHA5/IPC1530 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR |