FDA Adverse Event
Malfunction
Summary report: N
INTELECT ADVANCE COMBO
MDR report key: 1181035
·
Received September 29, 2008
Report
- Report Number
- 1022819-2008-00217
- Event Type
- Malfunction
- Date Received
- September 29, 2008
- Date of Event
- April 9, 2007
- Report Date
- April 9, 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
- TU
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS FOR EXPORT ONLY.
Description of Event or Problem · 1
A PATIENT COMPLAINED ON UN-INTENDED SHOCKING DURING AN ELECTROTHERAPY TREATMENT. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELECT ADVANCE COMBO | IPF, IMG, GZJ, HCC, GZI | IPF | CHATTANOOGA GROUP | 2772MC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |