MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-09 for CHATTA/FLU 115D manufactured by Chattanooga Corp..
[1482697]
Hot dry air / fluidized unit used on ph arm. Ph c/o hot and burning. Arm red. No blister ice applied. Had minimal redness when leaving rehab outpatient department. Follow-up. No redness or burn per patient. (b) (4) biomed department found nothing in error noted. Did have a noise so motor was changed. Was cleared and placed back in service. Highest temperature reached 115 degrees.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015103 |
| MDR Report Key | 1630804 |
| Date Received | 2010-03-09 |
| Date of Report | 2010-03-05 |
| Date of Event | 2010-01-19 |
| Date Added to Maude | 2010-03-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | HOT DRY AIR/FLUIDIZED MEDIUM UNIT |
| Product Code | LSB |
| Date Received | 2010-03-09 |
| Model Number | CHATTA/FLU 115D |
| ID Number | CONTROL #401896761 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-09 |