MAUDE Adverse Event Report: UNKNOWN ANESTHESIA MACHINE; GAS-MACHINE, ANESTHESIA

Lot Number 117385

Device Problem Disconnection (1171)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Date 01/19/2023

Event Type  malfunction  

Event Description

Anesthesia machine was being used.Part way through the case the monitor for 02 sats disconnected from the computer.This caused the 02 sats to be unmonitored.Patient desaturated and went into bradycardia, 30's.Procedure was aborted.Pt was bagged.Pt woke up.Pt did not receive full test.

• Brand Name: ANESTHESIA MACHINE
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16296084
• MDR Text Key: 308914405
• Report Number: MW5114678
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 117385
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White