MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for COBRA manufactured by Neurovision Medical Products, Inc..
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After intubation, surgeon noted that the nim tubing was not connecting to nim machine. Informed crna and called anesthesiologist to resolve issues. Noted blue electrode from nim tube failed to be recognized by the machine. Anesthesiologist replaced nim tube right away and solved the issues. Failed nim tube reported defects to manufacturer and sent report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9859575 |
| MDR Report Key | 9859575 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-02-13 |
| Report Date | 2020-02-13 |
| Date Reported to FDA | 2020-02-13 |
| Date Reported to Mfgr | 2020-03-20 |
| Date Added to Maude | 2020-03-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | COBRA |
| Generic Name | TUBE, TRACHEAL (W/WO CONNECTOR) |
| Product Code | BTR |
| Date Received | 2020-03-20 |
| Lot Number | C090319 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEUROVISION MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 353 SAN JON RD VENTURA CA 93001 US 93001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |