MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-05-05 for RUSCH MRI COND FIBER OPTIC LARYN KIT 005852300 manufactured by Teleflex.
[4496565]
The event is reported as: the customer alleges that the laryngoscope did not light up. When the tech attempted to remove the battery, the tab was either already broken in the handle or it broke during extraction of the battery. No report of pt injury or harm.
Patient Sequence No: 1, Text Type: D, B5
[12036439]
Product usage when alleged defect was encountered is unk at the time of this report. It is unk if the device sample is available for eval.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1044475-2014-00130 |
MDR Report Key | 3908708 |
Report Source | 06,07 |
Date Received | 2014-05-05 |
Date of Report | 2014-04-11 |
Date of Event | 2014-04-11 |
Date Mfgr Received | 2014-04-11 |
Date Added to Maude | 2014-07-15 |
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 | 0 |
Reporter Occupation | BIOMEDICAL ENGINEER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Contact | MARGIE BURTON, RN |
Manufacturer Street | PO BOX 12600 |
Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
Manufacturer Country | US |
Manufacturer Postal | 27709 |
Manufacturer Phone | 9194334965 |
Manufacturer G1 | TELEFLEX MEDICAL |
Manufacturer Street | 2917 WECK DR. |
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 | 2014-05-05 |
Catalog Number | 005852300 |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TELEFLEX |
Manufacturer Address | RESEARCH TRIANGLE PARK NC 27709 US 27709 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2014-05-05 |