MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1996-10-07 for BARIFLOW 880 manufactured by Therapex.
[25133]
Technologist claimed he said he saw a "flame" or a "brightness" and had a burning odor.
Patient Sequence No: 1, Text Type: D, B5
[7766499]
Investigation results: an evaluation of the return sample confirms that the device needed repair due to normal "wear and tear" of the unit and not due to any defect from the mfr. Corrective action: bariflow cat. #800, serial #ga1668 was refurbished. The main switch, foot switch and motor was replaced to balance hammer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2411512-1996-00029 |
| MDR Report Key | 44660 |
| Report Source | 06 |
| Date Received | 1996-10-07 |
| Date of Report | 1996-09-26 |
| Date of Event | 1996-08-29 |
| Date Added to Maude | 1996-10-28 |
| 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 | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARIFLOW |
| Generic Name | AUTOMATIC REMOTE FLOW CONTROL SYSTEM |
| Product Code | FCD |
| Date Received | 1996-10-07 |
| Model Number | NA |
| Catalog Number | 880 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 45573 |
| Manufacturer | THERAPEX |
| Manufacturer Address | 11100 COLBERT ANJOU QUEBEC CANADA CA HIJ2M9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-10-07 |