MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-24 for KING VISION KIT manufactured by Ambu / King Systems Corporation.
[146342623]
When trying to place the device in the pt's mouth, the camera mounted hits the lucas device. The camera was on, and i pulled it off to make room and the screen went dark. When trying to power the camera back on, it was dead. We replaced the batteries and attempted once more. When we slid the screen back into position it was showing highlighter green and purple (it looked like night vision looking towards a direct light source). With minor adjustments to the screen being seated we got the picture back. However, considerable time was taken attempting to troubleshoot the camera. At shift change, a supv looked over the king vision and found the same issue with the bad connection resulting in a highlighter green screen. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086910 |
| MDR Report Key | 8645799 |
| Date Received | 2019-05-24 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-05-16 |
| Date Added to Maude | 2019-05-28 |
| 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 KIT |
| Generic Name | LARYNGOSCOPE KIT |
| Product Code | OGH |
| Date Received | 2019-05-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | AMBU / KING SYSTEMS CORPORATION |
| Brand Name | KING VISION KIT |
| Generic Name | LARYNGOSCOPE KIT |
| Product Code | OGH |
| Date Received | 2019-05-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMBU KING SYSTEMS CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-24 |