MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-10-04 for WELCH ALLYN 56903 NA manufactured by Welch Allyn Inc..
[433019]
Doctor tried to intubate a patient who collapsed in a parking lot. Light in laryngoscope would not stay on due to failure of cap which holds light source in place. Doctor was unable to intubate and patient died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1619634-2005-00001 |
| MDR Report Key | 639943 |
| Date Received | 2005-10-04 |
| Date of Report | 2005-10-04 |
| Date of Event | 2005-09-15 |
| Date Facility Aware | 2005-09-29 |
| Report Date | 2005-10-04 |
| Date Reported to FDA | 2005-10-04 |
| Date Reported to Mfgr | 2005-10-04 |
| Date Added to Maude | 2005-10-12 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | WELCH ALLYN |
| Generic Name | 3 1/2" DISPOSABLE MACINTOSH LARYNGOSCOPE |
| Product Code | EQN |
| Date Received | 2005-10-04 |
| Returned To Mfg | 2005-09-20 |
| Model Number | 56903 |
| Catalog Number | NA |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 10 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 629471 |
| Manufacturer | WELCH ALLYN INC. |
| Manufacturer Address | * SKANEATELES FALLS NY * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2005-10-04 |