MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-05-30 for RUSCH EMERALD FO MACINTOSH BLADE 004434400 manufactured by Teleflex.
[4584815]
The pt is reported as: the customer alleges that the blade would not attach to the needle. The intubation was delayed until another laryngoscope set was obtained for pt use. No pt injury.
Patient Sequence No: 1, Text Type: D, B5
[12144298]
The complaint sample is not available for investigation. A visual, functional and dimensional inspection was not be conducted due to lack of the device sample. The dhr (device history record) file is not available for review in the u. S. The complaint sample is not available for investigation. The complaint cannot be confirmed. No corrective/preventative actions will be assigned. The root cause cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2014-00162 |
| MDR Report Key | 3908271 |
| Report Source | 07 |
| Date Received | 2014-05-30 |
| Date of Report | 2014-05-14 |
| Date of Event | 2014-05-05 |
| Date Mfgr Received | 2014-05-14 |
| 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 |
| 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 | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | 2917 WECK DR. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH EMERALD FO MACINTOSH BLADE |
| Generic Name | LARYNGOSCOPE BLADE |
| Product Code | CAL |
| Date Received | 2014-05-30 |
| Catalog Number | 004434400 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | RTP NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-30 |