MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-03-27 for RUSCH MRI COND FIBER OPTIC LARYN KIT 005852300 manufactured by Teleflex Medical.
[5599821]
The customer alleges that the mac 2 blade is flickering and failing.
Patient Sequence No: 1, Text Type: D, B5
[13044658]
(b)(4). The complaint case sample was rec'd w/some outward damage noticeable to the plastic carrying case. One of the locking latches was missing/broken off the case. Upon opening the kit it was also noted that one of the focs light pipes had been removed from a blade and was laying loose in the case. Also, during visual inspection the handle did not have a battery pack installed, and there were no loose battery packs in the carrying case. Since the laryngoscope handle did not arrive w/ a battery pack installed, a known good kit battery pack (new design) was installed into the handle. Multiple focs blades from the kit were attached to the handle and engaged. All of the blade lights were energized w/no flickering, no interruptions. The complaint cannot be confirmed. No corrective/preventative actions assigned. No further action required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2015-00141 |
| MDR Report Key | 4658477 |
| Report Source | 06,07 |
| Date Received | 2015-03-27 |
| Date of Report | 2015-03-11 |
| Date of Event | 2015-03-11 |
| Date Mfgr Received | 2015-03-11 |
| Date Added to Maude | 2015-05-11 |
| 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 | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 2917 WECK DR. |
| 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 | LARYNGOSCOPE KIT |
| Product Code | OGH |
| Date Received | 2015-03-27 |
| Returned To Mfg | 2015-03-19 |
| Catalog Number | 005852300 |
| Lot Number | 103301 |
| Device Availability | Y |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-27 |