FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2030498
·
Received March 9, 2011
Report
- Report Number
- 1720753-2011-02048
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Date of Event
- February 18, 2011
- Report Date
- March 9, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE POWER CONNECTIONS WERE CHECKED AND THE POWER SUPPLY WAS ADJUSTED. THE MFR'S SERVICE REP SUGGESTED REPLACEMENT OF THE TECHNIQUE PROCESSOR, HOWEVER, THE CUSTOMER HAS NOT DECIDED TO DO SO AT THIS TIME. NO FURTHER INFO IS AVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9600 SYSTEM SHUT DOWN DURING A CASE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |