MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2008-01-11 for INTELECT MOBILE COMBO 2778 manufactured by Chattanooga Group.
[791484]
The device was reported to shock patients on channel 2. Upon evaluation, the unit was found to have an incorrect output parameters on channel 2. It would produce a high voltage pulse at low settings, this would occur from as low as 0. 1ma output. The waveform is badly distorted. No patient data, treatment parameters, and resulting conditions/parameters was provided. No reported injury treatment and/or post injury treatment was noted from the complainant.
Patient Sequence No: 1, Text Type: D, B5
[8087739]
The device was evaluated by field staff. The device stim board was replaced and the device functioned as intended. The printed circuit board was returned for evaluation by engineering. The evaluation determined a transient over-voltage on the stimulator printed circuit board which result in components on the board to malfunction resulting in the shock to the patient. The pcb software version 2. 3 or higher will prevent the effects of an over-voltage in this circuitry.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00014 |
| MDR Report Key | 979469 |
| Report Source | 01,06,08 |
| Date Received | 2008-01-11 |
| Date of Report | 2008-01-10 |
| Date of Event | 2007-10-05 |
| Date Mfgr Received | 2007-10-05 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2008-04-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238702281 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTELECT MOBILE COMBO |
| Generic Name | POWER MUSCLE STIMULATOR |
| Product Code | LIH |
| Date Received | 2008-01-11 |
| Returned To Mfg | 2007-10-29 |
| Model Number | 2778 |
| Catalog Number | 2778 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 981953 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-01-11 |