MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-09-23 for M-4 120V W/PKS 2502 manufactured by Chattanooga Group.
[18079083]
The device has been received and is currently under eval. The device eval and any add'l findings will be provided upon conclusion of the device eval.
Patient Sequence No: 1, Text Type: N, H10
[18375696]
The device failed during the electrical current leakage test. The device had been received by the clinic and delivered to the biomedical dept for acceptance testing. The biomedical staff removed the device from the shipping crate. The staff noted that the device and shipping container was in satisfactory condition. The device was filled with water and the test device was placed in series with the ac mains power. Ac mains power was applied to the device. After a few moments with ac mains applied, the electrical current leakage tester began to emit fumes and smoke. The tech terminated the testing and removed ac mains from the device. Post inspection of the test device revealed that it had received undetermined damaged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1022819-2008-00192 |
| MDR Report Key | 2063354 |
| Report Source | 06 |
| Date Received | 2008-09-23 |
| Date of Report | 2008-07-11 |
| Date of Event | 2008-07-11 |
| Date Mfgr Received | 2008-07-11 |
| Device Manufacturer Date | 2008-06-01 |
| Date Added to Maude | 2011-04-22 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | M-4 120V W/PKS |
| Product Code | IRQ |
| Date Received | 2008-09-23 |
| Returned To Mfg | 2008-07-24 |
| Model Number | 2502 |
| Catalog Number | M-4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-23 |