MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-20 for WESTMED 8677 manufactured by Westmed.
[24221192]
The anesthesia circuit had been fully tested prior to the pt arrival to the operating room and functioning. After intubation, the pt and table were re-positioned to facilitate ent surgery and as the pt and table were being re-positioned 180 degrees, one half of the circuit broke in half. The surgeon was informed and asked to stop operating while the provider quickly changed the circuit. While no harm reached the pt, it had the potential to lead to a respiratory event and lack of anesthesia received. Pt was intubated at the time and receiving desflurane, n2o, and plasmalyte. Other anesthetic drugs administered during the procedure prior to the event include midazolam, fentanyl, lidocaine, propofol, rocuronium and dexamethasone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5055736 |
| MDR Report Key | 5032547 |
| Date Received | 2015-08-20 |
| Date of Report | 2015-08-20 |
| Date of Event | 2015-08-17 |
| Date Added to Maude | 2015-08-26 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WESTMED |
| Generic Name | ANESTHESIA BREATHING CIRCUIT |
| Product Code | OFP |
| Date Received | 2015-08-20 |
| Model Number | 8677 |
| Lot Number | 06302015T59 |
| ID Number | 96 INCH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WESTMED |
| Manufacturer Address | TUCSON AZ 85706 US 85706 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-20 |