MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-08-25 for * manufactured by Gyrus Acmi, Inc..
[8092464]
Product not being retured to acmi for eval. Investigation inconclusive, root cause cannot be determined. Historical data indicates that problems of this nature are the result of incorrect assembly of the device by the user. Device labeling has explicit instructions regarding the proper assembly of the blade extender and the laryngoscope blade. When properly assembled, the blade extender requries a "blade extender remover," lar-er, to remove the extender from the laryngoscope. A final report will be submitted if add'l info surfaces.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519132-2004-00054 |
| MDR Report Key | 965274 |
| Report Source | 07 |
| Date Received | 2004-08-25 |
| Device Manufacturer Date | 2003-07-01 |
| Date Added to Maude | 2007-12-18 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | GRACIELA DENIS |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042600 |
| Manufacturer G1 | ACMI NORWALK |
| Manufacturer Street | 93 NORTH PLEASANT ST |
| Manufacturer City | NORWALK OH 44857040 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44857 0409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | EQN |
| Date Received | 2004-08-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 934897 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | 93 NORTH PLEASANT ST. NORWALK OH 44857 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-08-25 |