MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-13 for MCGRATH 500-000-000- manufactured by Aircraft Medical Limited.
[127062042]
Title randomized trial of video laryngoscopy for endotracheal intubation of critically ill adults source clinical investigations. 11 (1980-1987), november 2016. Article number: 44. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[127062043]
According to literature source of study performed, the device was used and was unable to intubate patient on first attempt due to poor camera image hence inability to pass an endotracheal tube into the trachea. It was reported that there were procedural complications such as aspiration, esophageal intubation, hypotension, hypoxia, cardiac arrest and airway trauma. Author: david r. Janz, md, 2016, the society of critical care medicine and wolters kluwer health, inc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010244187-2018-00003 |
| MDR Report Key | 8067312 |
| Date Received | 2018-11-13 |
| Date of Report | 2018-11-13 |
| Date of Event | 2016-11-01 |
| Date Mfgr Received | 2018-10-19 |
| Date Added to Maude | 2018-11-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | AIRCRAFT MEDICAL LIMITED |
| Manufacturer Street | 7 CROSS WAY |
| Manufacturer City | DALGETY BAY,FI KY119JE |
| Manufacturer Country | GB |
| Manufacturer Postal Code | KY11 9JE |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MCGRATH |
| Generic Name | LARYNGOSCOPE, NON-RIGID |
| Product Code | CAL |
| Date Received | 2018-11-13 |
| Model Number | 500-000-000- |
| Catalog Number | 500-000-000- |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIRCRAFT MEDICAL LIMITED |
| Manufacturer Address | 7 CROSS WAY DALGETY BAY,FI KY119JE GB KY11 9JE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-13 |