MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-10-06 for DISPOSABLE LARYNGOSCOPE * manufactured by Welch Allyn.
[516979]
These came in an emergency kit (stat kit 600). The larger one was used in a resuscitation attempt in our parking lot after a pt collapsed on the way to his car. The product failed. I was unable to intubate him becasue of a light failure. The pt died. The problem seems to be in the design of the screw cap. While it will light, it will not stay lit. When using the device, you are holding it with the left hand and inserting a tube with your right hand. It is impossible to adjust the cap when the light goes out in this position. I recommend you recall this product immediately.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036847 |
| MDR Report Key | 746584 |
| Date Received | 2005-10-06 |
| Date Added to Maude | 2006-08-14 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE LARYNGOSCOPE |
| Generic Name | * |
| Product Code | EQN |
| Date Received | 2005-10-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 734381 |
| Manufacturer | WELCH ALLYN |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-10-06 |