MAUDE Adverse Event Report: GE HEALTHCARE/DATEX-OHMEDA, INC. AVANCE ANESTHESIA UNIT; GAS-MACHINE, ANESTHESIA

Device Problem Short Fill (1575)

Patient Problems Cardiopulmonary Arrest (1765); Low Oxygen Saturation (2477)

Event Date 01/23/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 a (b)(6) yo male underwent a right knee l&d w/ spinal anesthesia.Procedure converted to general anesthesia for pain management, patient was induced w/ propofol & succinylcholine.Patient was ventilated with anesthesia circuit, then manually by ambu bag as bag was unable to fill with 02 flush or high flow 02.Patient intubated w/ minimal desat during induction; patient went asystole, acls started.Procedure aborted.Patient to icu intubated and w/o response, sedated and paralyzed as per hypothermic protocol.

• Brand Name: AVANCE ANESTHESIA UNIT
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): GE HEALTHCARE/DATEX-OHMEDA, INC.
• MDR Report Key: 8343229
• MDR Text Key: 137075283
• Report Number: MW5084084
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 65 YR
• Patient Weight: 127