MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-10-06 for RUSCH GREENSPEC FIBER OPTIC MEDIUM HANDLE 004411100 manufactured by Teleflex Medical.
[16370593]
Incident reported as: a code was called on a pt and the staff pulled the intubation tray. While in process of resuscitating the pt, the light on the handle did not come on. The staff had to retrieve another intubation tray. The pt subsequently died. No further info available.
Patient Sequence No: 1, Text Type: D, B5
[16654677]
Sample requested, but not returned yet. Investigation ongoing and a follow up report will be sent as soon as it is available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2008-00034 |
| MDR Report Key | 1190229 |
| Report Source | 06 |
| Date Received | 2008-10-06 |
| Date of Report | 2008-09-24 |
| Date Mfgr Received | 2008-09-24 |
| Date Added to Maude | 2008-10-14 |
| 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 | ANGELA BROWN, MGR |
| Manufacturer Street | 4024 STIRRUP CREEK DRIVE |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9194334901 |
| 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 GREENSPEC FIBER OPTIC MEDIUM HANDLE |
| Generic Name | FIBER OPTIC HANDLE |
| Product Code | EQN |
| Date Received | 2008-10-06 |
| Model Number | NA |
| Catalog Number | 004411100 |
| Lot Number | 074901 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1229819 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC 27709 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-10-06 |