MAUDE Adverse Event Report: WESTMED WESTMED; ANESTHESIA BREATHING CIRCUIT

Model Number 8677

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2015

Event Type  malfunction  

Event Description

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.

• Brand Name: WESTMED
• Type of Device: ANESTHESIA BREATHING CIRCUIT
• Manufacturer (Section D): WESTMED; tucson AZ 85706
• MDR Report Key: 5032547
• MDR Text Key: 24221192
• Report Number: MW5055736
• Device Sequence Number: 1
• Product Code: OFP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8677
• Device Lot Number: 06302015T59
• Other Device ID Number: 96 INCH
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 78