MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-05-20 for RUSCH GREENSPEC FO HANDLE, MEDIUM 004411100 manufactured by Teleflex.
[3564258]
The event is reported as: the biomed technician states that the handle would heat up if the laryngoscope blade was attached to the handle and left on. Biomed noticed this during maintenance that the insulator ring in the head of the handle was either damaged or missing. No pt injury/involvement reported.
Patient Sequence No: 1, Text Type: D, B5
[10744847]
The device sample was not returned for eval at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2013-00074 |
| MDR Report Key | 3127285 |
| Report Source | 06 |
| Date Received | 2013-05-20 |
| Date of Report | 2013-04-30 |
| Date of Event | 2013-04-24 |
| Date Mfgr Received | 2013-04-30 |
| Date Added to Maude | 2013-07-26 |
| 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 | PO BOX 12600 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX |
| 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 FO HANDLE, MEDIUM |
| Generic Name | FIBEROPTIC LARYNGOSCOPE HANDLE |
| Product Code | EQN |
| Date Received | 2013-05-20 |
| Catalog Number | 004411100 |
| Device Availability | Y |
| 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 | 2013-05-20 |