FDA Adverse Event
Malfunction
Summary report: N
INTELECT ADVANCED 2CH COLOR COMBO W/EMG
MDR report key: 1180909
·
Received September 29, 2008
Report
- Report Number
- 1022819-2008-00221
- Event Type
- Malfunction
- Date Received
- September 29, 2008
- Date of Event
- April 13, 2007
- Report Date
- April 13, 2007
- Manufacturer
- CHATTANOOGA GROUP
- Product Code
- IPF
- Removal / Correction Number
- 1022819-11/15/2008-001-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RP
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS FOR EXPORT ONLY.
Description of Event or Problem · 1
UNIT PRODUCES A HIGH OUTPUT OF STIM ON THE CH1. THE WAVEFORM BEING USED IS SYMMETRICAL BIPHASIC ON CH1 WITH INTENSITY SET AT 0 AND TREATMENT TIME FOR 20 MINUTES. NO PATIENT DATA WAS PROVIDED BY THE COMPLAINANT. THIS MALFUNCTION CAUSES THE PRINTED CIRCUIT BOARD TO CHANGE THE STIMULATORY PATIENT 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 ADVANCED 2CH COLOR COMBO W/EMG | IPF, IMG, GZJ, HCC, GZI | IPF | CHATTANOOGA GROUP | 2762CC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |