MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-24 for OPERON OT 1702104 manufactured by Berchtold Gmbh & Co. Kg.
[180557027]
The patient was being positioned on the surgical bed when the certified registered nurse anesthetist noticed that smoke was coming from the power outlet on the bed. The patient's stretcher was immediately brought back into the room and the patient was positioned back onto the stretcher. The surgical bed was then taken out of the operating room and a new bed was brought into the operating room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9744953 |
| MDR Report Key | 9744953 |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-02-04 |
| Report Date | 2020-02-11 |
| Date Reported to FDA | 2020-02-11 |
| Date Reported to Mfgr | 2020-02-24 |
| Date Added to Maude | 2020-02-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | OPERON |
| Generic Name | TABLE, OPERATING-ROOM, ELECTRICAL |
| Product Code | GDC |
| Date Received | 2020-02-24 |
| Model Number | OT 1702104 |
| Catalog Number | OT 1702104 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BERCHTOLD GMBH & CO. KG |
| Manufacturer Address | 571 SILVERON BLVD. FLOWER MOUND TX 75028 US 75028 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-24 |