FDA Adverse Event
Malfunction
Summary report: N
INTELECT ADVANCED COMBO MONOCHROME
MDR report key: 1180936
·
Received September 29, 2008
Report
- Report Number
- 1022819-2008-00244
- Event Type
- Malfunction
- Date Received
- September 29, 2008
- Date of Event
- June 8, 2007
- Report Date
- June 8, 2007
- Manufacturer
- CHATTANOOGA GROUP
- Product Code
- IPF
- Removal / Correction Number
- 1022819-11/15/2007-001-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PE
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS FOR EXPORT ONLY.
Description of Event or Problem · 1
PATIENT RECEIVED STRONG SURGE DURING 4POLE INTERFERENTIAL TREATMENT. MACHINE GAVE ERROR 301 STIM BOARD FAILURE ERROR MESSAGE. 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 COMBO MONOCHROME | IPF, IMG, GZJ, HCC, GZI | IPF | CHATTANOOGA GROUP | 2772MC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |