MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-25 for DAC II DAC2 manufactured by Dade Div. Baxter Healthcare Corp..
[6221]
Equipment worked well at beginning of shift. Around 10 am it would not start cycle so it was reset by turning off and on. When it was used a short time later it would not start again so it was unplugged for a brief time. When it still would not start the fuses were checked. It was turned off and on several more times but would not start. It was left plugged in with the lid closed. About 11:30 rptr smelled smoke and saw that it was coming from the cell washer. Unplugged equipment and called for fire crew.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1002927 |
| MDR Report Key | 14860 |
| Date Received | 1994-07-25 |
| Date of Report | 1994-07-14 |
| Date of Event | 1994-07-09 |
| Date Added to Maude | 1994-07-26 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAC II |
| Generic Name | AUTOMATIC TUBE WASHER |
| Product Code | KSN |
| Date Received | 1994-07-25 |
| Model Number | DAC2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14854 |
| Manufacturer | DADE DIV. BAXTER HEALTHCARE CORP. |
| Manufacturer Address | MIAMI FL 331520672 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-07-25 |