MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-15 for KING VISION VIDEO LARYNGOSCOPE manufactured by Ambu / King Systems.
[117461957]
Device failed without warning during use while attempting endotracheal intubation of a pt in cardiac arrest. Dates of use: 5 years. Diagnosis or reason for use: video assisted endotracheal intubation. Is the product compounded: no; is the product over-the-counter: no. Event reappeared after reintroduction: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079168 |
| MDR Report Key | 7788878 |
| Date Received | 2018-08-15 |
| Date of Report | 2018-08-14 |
| Date of Event | 2018-07-08 |
| Date Added to Maude | 2018-08-16 |
| 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 | 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 | 0 |
| Brand Name | KING VISION VIDEO LARYNGOSCOPE |
| Generic Name | LARYNGOSCOPE KIT |
| Product Code | OGH |
| Date Received | 2018-08-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMBU / KING SYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-08-15 |