MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-30 for ANESTHESIA BREATHING CIRCUIT KIT 9313 manufactured by Westmed, Inc..
[61151711]
Patient Sequence No: 1, Text Type: N, H10
[61151712]
During surgery, anesthesiologist suspected patient was not responding to anesthetic agent, sevoflurane. Case was just getting started. At first it was thought that the problem was with the anesthesia ventilator, but md requested switching out the patient's breathing circuit. Problem was resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6135884 |
| MDR Report Key | 6135884 |
| Date Received | 2016-11-30 |
| Date of Report | 2016-10-08 |
| Date of Event | 2016-09-08 |
| Report Date | 2016-10-08 |
| Date Reported to FDA | 2016-10-08 |
| Date Reported to Mfgr | 2016-10-08 |
| Date Added to Maude | 2016-11-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANESTHESIA BREATHING CIRCUIT KIT |
| Generic Name | ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC) |
| Product Code | OFP |
| Date Received | 2016-11-30 |
| Returned To Mfg | 2016-10-03 |
| Catalog Number | 9313 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WESTMED, INC. |
| Manufacturer Address | 5580 S. NOGALES HWY. TUCSON AZ 85706 US 85706 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-30 |