MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-14 for LIEBEL-FLARSHEIM MALLINCKRODT HYDRA VISION PLUS DR manufactured by Liebel-flarsheim Mallinckrodt.
[133713917]
During use, whitish acrid smelling smoke was noted to be rising from top of cabinet. There were no flames seen. Power supply to the device was disconnected and the smoke and smell began to dissipate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8266385 |
| MDR Report Key | 8266385 |
| Date Received | 2019-01-14 |
| Date of Report | 2019-01-11 |
| Date of Event | 2019-01-09 |
| Date Facility Aware | 2019-01-01 |
| Report Date | 2019-01-11 |
| Date Reported to FDA | 2019-01-11 |
| Date Added to Maude | 2019-01-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIEBEL-FLARSHEIM MALLINCKRODT HYDRA VISION PLUS DR |
| Generic Name | HYDRA VISION PLUS DR VERTICAL DIAGNOSTIC BUCK |
| Product Code | IXR |
| Date Received | 2019-01-14 |
| Model Number | HYDRA VISION PLUS D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 15 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM MALLINCKRODT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-01-14 |