FDA Adverse Event
Malfunction
Summary report: N
NDM
MDR report key: 233427
·
Received July 23, 1999
Report
- Report Number
- 1720159-1999-00056
- Event Type
- Malfunction
- Date Received
- July 23, 1999
- Report Date
- June 29, 1999
- Manufacturer
- ASPEN LABORATORIES, INC.
- Product Code
- GEI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
HOSPITAL BIOMED TESTED THE SYSTEM 4400 ELECTROSURGICAL UNIT, A SAMPLE CONMED PENCIL #130307 AND A PAD (MANUFACTURER WAS UNKNOWN). THE PENCIL AND ESU TESTED OUT TO BE WORKING PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NDM | ELECTROSURGICAL UNIT | GEI | ASPEN LABORATORIES, INC. | SYSTEM 4400 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | DISPERSIVE ELECTRODE-MFR UNKNOWN. |