MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-09-29 for SS-2 120V W/O PKS 2304 manufactured by Chattanooga Group.
[2747691]
A ss-2 hydrocollator hot pack heating unit overheated. The unit began to smoke and emit flames from under the heating tank lid. An employee of the facility contacted the fire dept at 6:24 am. The fire dept was dispatched, as a non-emergency dispatch, to the facility. The fire dept removed the device from the facility. The device tank was filled with water to extinguish the flames. The fire dept noted a small amount of scorching on the facility wall where the device had been positioned. The facility had a light haze of smoke, thus ventilation fans were positioned to remove the smoke. The ventilation was operated until 7:15 am. The hydrocollator was purchased in (b)(6) 2008. Upon placing in service the device would malfunction by boiling the tank water. A call was made to the distributor requesting a replacement and the distributor suggested replacing the thermostat. A replacement thermostat was sent to the customer and the physical therapist replaced the thermostat. The client said that the unit continued to boil and they were concerned. Another call was made requesting a replacement hydrocollator just before the fire occurred. The water level in the hydrocollator was checked the day before.
Patient Sequence No: 1, Text Type: D, B5
[9965736]
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
| Report Number | 1022819-2008-00265 |
| MDR Report Key | 2555645 |
| Report Source | 05 |
| Date Received | 2008-09-29 |
| Date of Report | 2008-09-04 |
| Date of Event | 2008-09-04 |
| Date Mfgr Received | 2008-09-05 |
| Date Added to Maude | 2012-05-03 |
| 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 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 | SS-2 120V W/O PKS |
| Product Code | IRQ |
| Date Received | 2008-09-29 |
| Returned To Mfg | 2008-09-15 |
| Model Number | 2304 |
| Catalog Number | 2304 |
| 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 | 2008-09-29 |