MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-07-06 for MCGRATH VIDEO LARYNGOSCOPE 500-000-000 manufactured by Aircradt Medical.
[2126551]
Customer stated the image goes out or black lines appear on the screen. While using the mcgrath, a patient went into cardiac arrest and died.
Patient Sequence No: 1, Text Type: D, B5
[9198831]
The mcgrath series 5 unit that was returned to manufacturer for further evaluations. The investigation found that "the device does not appear to function "out of family" for this revision/age of unit and no evidence of the issue experienced by the user could be replicated while using good quality batteries. Therefore, the quality and suitability of the power source (battery) used during the procedure would appear to be the most likely cause of the degradation in function at the time of the event. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2086507-2011-00001 |
| MDR Report Key | 2159522 |
| Report Source | 08 |
| Date Received | 2011-07-06 |
| Date of Report | 2011-07-06 |
| Date of Event | 2009-10-16 |
| Date Mfgr Received | 2009-10-16 |
| Date Added to Maude | 2011-07-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATE RIZZO, SR. MGR. |
| Manufacturer Street | 4660 LA JOLLA VILLAGE DRIVE SUITE 900 |
| Manufacturer City | SAN DIEGO CA 92122 |
| Manufacturer Country | US |
| Manufacturer Postal | 92122 |
| Manufacturer Phone | 8586225621 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCGRATH VIDEO LARYNGOSCOPE |
| Generic Name | SERIES 5 VIDEO LARYNGOSCOPE |
| Product Code | ENZ |
| Date Received | 2011-07-06 |
| Returned To Mfg | 2010-12-15 |
| Catalog Number | 500-000-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIRCRADT MEDICAL |
| Manufacturer Address | EDINBURGH UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2011-07-06 |