MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-09 for RUSCH GREEN LITE MILLER 2 manufactured by Teleflex.
[69963381]
Our quality improvement committee received two separate reports of the rusch green life miller #2 or #3 blade's light pipe breaking off the blade with normal use. Luckily the broken piece was recovered from patient's mouth during intubation. Also, the light source occasionally does not work intermittently during laryngoscopy. I have evaluated the blades myself and the mac blade's light pipe seems well seated in the blade, but the miller blade's light pipe does have potential to slip out of the blade and break off with moderate force.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068401 |
| MDR Report Key | 6399040 |
| Date Received | 2017-03-09 |
| Date of Report | 2017-03-09 |
| Date of Event | 2017-03-08 |
| Date Added to Maude | 2017-03-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RUSCH GREEN LITE |
| Generic Name | RUSCH GREEN LITE |
| Product Code | EQH |
| Date Received | 2017-03-09 |
| Model Number | MILLER 2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | 3015 CARRINGTON MILL BLVD. NC 27560 US 27560 |
| Brand Name | RUSCH GREEN LITE |
| Generic Name | RUSCH GREEN LITE |
| Product Code | EQH |
| Date Received | 2017-03-09 |
| Model Number | MILLER 2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | 3015 CARRINGTON MILL BLVD. NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-09 |