MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-10-09 for E-1 120V W/PKS 2102 manufactured by Chattanooga Group.
[20240708]
The heating element on the device has rusted almost all of the way through and has gotten rust stains on the bottom of the unit, rack and hot packs. The heating element has been changed previous to this instance. No operator or patient injuries resulted.
Patient Sequence No: 1, Text Type: D, B5
[20548675]
Awaiting evaluation of device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00288 |
| MDR Report Key | 1197791 |
| Report Source | 05 |
| Date Received | 2008-10-09 |
| Date of Report | 2008-09-09 |
| Date of Event | 2008-09-09 |
| Date Mfgr Received | 2008-09-09 |
| Date Added to Maude | 2009-07-14 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS ROAD |
| 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 | E-1 120V W/PKS |
| Product Code | IRQ |
| Date Received | 2008-10-09 |
| Returned To Mfg | 2008-09-30 |
| Model Number | 2102 |
| Catalog Number | 2102 |
| 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 | 2008-10-09 |