MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-01 for KING VISION manufactured by King Systems (ambu).
[41950472]
The king vision video laryngoscope was used during a first attempt of endotracheal intubation. During the attempt, the user identified a foreign object in the airway. The king vision was set down while the foreign object was being removed. The king vision was again picked up to be used for a second attempt of endotracheal intubation when it was identified that the unit was still powered on, but the video screen was no longer functioning. The king vision was set aside and fiberoptic laryngoscopy was used to perform the endotracheal intubation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061451 |
| MDR Report Key | 5546805 |
| Date Received | 2016-04-01 |
| Date of Report | 2016-03-18 |
| Date of Event | 2016-03-17 |
| Date Added to Maude | 2016-04-05 |
| 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 |
| 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 |
| Generic Name | KING VISION |
| Product Code | OGH |
| Date Received | 2016-04-01 |
| Returned To Mfg | 2016-03-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KING SYSTEMS (AMBU) |
| Manufacturer Address | NOBLESVILLE IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-01 |