FDA Adverse Event
Malfunction
Summary report: N
INTELECT MOBILE COMBO
MDR report key: 1180923
·
Received September 29, 2008
Report
- Report Number
- 1022819-2008-00232
- Event Type
- Malfunction
- Date Received
- September 29, 2008
- Date of Event
- December 4, 2006
- Report Date
- December 4, 2006
- Manufacturer
- CHATTANOOGA GROUP
- Product Code
- IPF
- Removal / Correction Number
- 1022819-11/15/2007-001-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS FOR EXPORT ONLY.
Description of Event or Problem · 1
THE DEVICE HAS A HIGH OUTPUT ON CHANNEL 2 WHEN INTENSITY IS RAISED TO 0.1MA. THE DEVICE SURGED/SHOCKED. THIS MALFUNCTION CAUSES THE PRINTED CIRCUIT BOARD TO CHANGE THE STIMULATORY PT OUTPUT FROM THE INTENDED OUTPUT TO AN UNINTENDED HIGHER VOLTAGE OUTPUT. WHEN SUCH A MALFUNCTION OCCURS, IT RESULTS IN A SHOCK SENSATION AND POSSIBLE BURN TO THE AREA BENEATH THE ELECTRODE PADS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELECT MOBILE COMBO | IPF, IMG, GZJ, GZI | IPF | CHATTANOOGA GROUP | 2778 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |