FDA Adverse Event
Malfunction
Summary report: N
INTELECT MOBILE COMBO
MDR report key: 1180939
·
Received September 29, 2008
Report
- Report Number
- 1022819-2008-00242
- Event Type
- Malfunction
- Date Received
- September 29, 2008
- Date of Event
- May 30, 2007
- Report Date
- May 30, 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
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS FOR EXPORT ONLY.
Description of Event or Problem · 1
PATIENT RECEIVED SHOCK DURING 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 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, HCC, GZI | IPF | CHATTANOOGA GROUP | 2778 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |