MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-07-01 for RUSCH MRI COND FIBER OPTIC LARYN KIT 005852300 manufactured by Teleflex Medical.
[19818290]
The customer alleges that the light bundle will not light on the mac 2 blade. Intubation was accomplished with a standard laryngoscope set. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[19867888]
(b)(4). The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[23950212]
(b)(4). The mri kit was returned for evaluation. A visual exam was performed and it was observed that the mac 2 blade was missing. The complaint was reported as the mac 2 blade would not energize when engaged on the handle. The mac 2 blade was not present in the kit; however, during functional testing of all of the returned blades, it was found that two of the blades would not energize: the mac 3, and the mil 1. The small incandescent bulbs which are seated in the focs light bundle were either defective or burned out. Based on the investigation performed, the reported complaint was confirmed. It should be noted that the blade that was reported defective was not returned, but there were defective blades in the kit. The root cause as to why the bulbs burned out could not be determined. A conclusion code could not be found as the complaint was confirmed, however, a root cause was not established.
Patient Sequence No: 1, Text Type: N, H10
[23950213]
The customer alleges that the light bundle will not light on the mac 2 blade. Intubation was accomplished with a standard laryngoscope set. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1044475-2015-00215 |
| MDR Report Key | 4883781 |
| Report Source | 06 |
| Date Received | 2015-07-01 |
| Date of Report | 2015-06-17 |
| Date of Event | 2014-06-18 |
| Date Mfgr Received | 2015-07-10 |
| Date Added to Maude | 2015-07-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 2917 WECK DRIVE |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH MRI COND FIBER OPTIC LARYN KIT |
| Generic Name | MRI LARYNGOSCOPE KIT |
| Product Code | OGH |
| Date Received | 2015-07-01 |
| Returned To Mfg | 2015-07-01 |
| Catalog Number | 005852300 |
| Lot Number | 132601 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-01 |