MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-02-20 for OXYGEN TENT CANOPY 2342/304-5061-300 2342-304-5061-300 manufactured by Ohmeda Medical, Part Of Ge Medical Systems.
[308709]
Tent set-up was in progress. Tent canopy was defective; product was torn/cut prior to its arrival at the hosp. The rt (respiratory therapist) does not use any sharp instruments when setting up a tent. The outer packaging did not show evidence of being cut or torn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 512243 |
| MDR Report Key | 512243 |
| Date Received | 2004-02-20 |
| Date of Report | 2003-12-01 |
| Date of Event | 2003-11-01 |
| Date Added to Maude | 2004-02-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXYGEN TENT CANOPY |
| Generic Name | CANOPY - PEDIATRIC AEROSOL |
| Product Code | BYK |
| Date Received | 2004-02-20 |
| Model Number | 2342/304-5061-300 |
| Catalog Number | 2342-304-5061-300 |
| Lot Number | 20401 |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 501240 |
| Manufacturer | OHMEDA MEDICAL, PART OF GE MEDICAL SYSTEMS |
| Manufacturer Address | 8880 GORMAN RD LAURAL MD 20723 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-02-20 |