MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-05 for GREEN RUSCHLITE 4551003 HANDLE 77700 manufactured by Teleflex.
[35014806]
Patient Sequence No: 1, Text Type: N, H10
[35014807]
An hour after return form cardiac surgery there was a loss of airway and attempts at various interventions, one of which involved the use of a disposable fiber-optic laryngoscope handle and blade assembly. Generally, the blade felt fully engaged but it was not. Light was projecting posteriorly with a dimmer projected light at the tip. This gave the end-user a false sense that the scope is ready to use which may contribute to a negative patient event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5343127 |
| MDR Report Key | 5343127 |
| Date Received | 2016-01-05 |
| Date of Report | 2015-11-11 |
| Date of Event | 2015-10-31 |
| Report Date | 2015-11-11 |
| Date Reported to FDA | 2015-11-11 |
| Date Reported to Mfgr | 2015-11-11 |
| Date Added to Maude | 2016-01-05 |
| 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 |
| 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 | GREEN RUSCHLITE |
| Generic Name | SOURCE, CARRIER, FIBEROPTIC LIGHT |
| Product Code | EQH |
| Date Received | 2016-01-05 |
| Model Number | 4551003 |
| Catalog Number | HANDLE 77700 |
| ID Number | BLADE MAC THOUGHT TO BE SIZE |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | 3015 CARRINGTON MILL BOULEVARD MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-05 |