MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-10 for MILLER 1 LARYNGOSCOPE BLADE * 5-5062-01 manufactured by Sunmed Llc.
[4993272]
Laryngoscope blades are noted to occasionally have dim bulbs and become extremely hot. New blades purchased and some of the new blades were noted to be having the same issues. The problem does not appear to be due to the age of the bulb or batteries. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039065 |
| MDR Report Key | 4253555 |
| Date Received | 2014-11-10 |
| Date of Report | 2014-11-10 |
| Date of Event | 2014-11-06 |
| Date Added to Maude | 2014-11-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILLER 1 LARYNGOSCOPE BLADE |
| Generic Name | LARYNGOSCOPE BLADE |
| Product Code | CAL |
| Date Received | 2014-11-10 |
| Model Number | * |
| Catalog Number | 5-5062-01 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNMED LLC |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-10 |