FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 873661
·
Received June 30, 2007
Report
- Report Number
- 9617766-2007-00101
- Event Type
- Malfunction
- Date Received
- June 30, 2007
- Date of Event
- June 7, 2007
- Report Date
- June 30, 2007
- Manufacturer
- GE OEC MEDICAL SYSEMS, 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
GEHC SURGERY SERVICE PERSONNEL REPLACED INTERCONNECT AND LEMO CONNECTOR TO REPAIR MOST LIKELY CAUSE OF SYSTEM RESET. REPLACED GENERATOR BATTERIES TO REPAIR CHARGER FAILED ERROR. SYSTEM NEEDS TO BE CHARGED ON A REGULAR BASIS. THIS CAN BE PERFORMED BY PLUGGING IN WORKSTATION TO C-ARM AND PLUGGING WORKSTATION TO WALL OUTLET. SYSTEM DOES NOT HAVE TO BE ON. ENTERED TEST PATIENT INFO AND LET SIT FOR 45 MIN. TOOK TEST IMAGES AND SAVED. SYSTEM FUNCTIONING AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED, SYSTEM NEEDED TO BE REBOOT BEFORE CASE. PATIENT INFO WAS ENTERED WELL BEFORE CASE. WHEN TECH RETURNED BEFORE CASE, GENERATOR WAS AT 20 BLOCKS. SYSTEM WAS REBOOTED BEFORE CASE BEGAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSEMS, INC | 8800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |