FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1151086
·
Received September 9, 2008
Report
- Report Number
- 1720753-2008-24773
- Event Type
- Malfunction
- Date Received
- September 9, 2008
- Date of Event
- August 7, 2008
- Report Date
- August 15, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP REMOVED AND REPLACED 110V 15AMP POWER CORD CABLE. HE RETIGHTENED ALL GROUND CABLES. CHECKED GROUND CONTINUITY THROUGH OUT CARM AND WORKSTATION. GROUND CONTINUITY TESTS AND CHECKS OUT OK. THE INHOUSE BIOMEDICAL ENGINEERING PERFORMED ELECTRICAL SAFETY TESTS BEFORE AND AFTER POWER CORD CABLE REPLACEMENT. ELECTRICAL SAFETY TESTS AND CHECKS OUT TO BE OK.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE POWER CORD IS TORN/FRAYED. NO PT INJURY WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |