MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-03-28 for QED-100 * manufactured by Anecare Laboratories, Inc..
[21623671]
Once pt's procedure was complete, the anesthesiologist was waking the patient up from anesthesia. Anesthesiologist used the qed-100 device to assist in waking the patient up faster. This device is designed to absorb the gas faster and raises the end title co2, which makes the patient spontaneously breathe on their own. After pt's airway was removed, the patient had difficulty breathing. The qed-100 device was immediately taken off and the patient's airway was secured with a laryngeal mask airway (lma). The lma was removed shortly after, at which time the patient began to breathe normally on their own.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 836125 |
| MDR Report Key | 836125 |
| Date Received | 2007-03-28 |
| Date of Report | 2007-03-28 |
| Date of Event | 2007-03-22 |
| Report Date | 2007-03-28 |
| Date Reported to FDA | 2007-03-28 |
| Date Added to Maude | 2007-04-12 |
| 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 | QED-100 |
| Generic Name | ANESTHESIA EMERGENCE DEVICE |
| Product Code | BYW |
| Date Received | 2007-03-28 |
| Model Number | QED-100 |
| Catalog Number | * |
| Lot Number | 06070003 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 823417 |
| Manufacturer | ANECARE LABORATORIES, INC. |
| Manufacturer Address | 3487 W. 2100 SOUTH, 100 SALT LAKE CITY UT 84119 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-28 |