MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I; GAS - MACHINE, ANESTHESIA

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 03/30/2018

Event Type  Injury  

Event Description

Etco2 water trap line became dislodged during airway management during a surgical procedure.

• Brand Name: FLOW-I
• Type of Device: GAS - MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; wayne NJ 07470
• MDR Report Key: 7493897
• MDR Text Key: 107783882
• Report Number: MW5077032
• 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: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• 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): Required Intervention
• Patient Age: 37 YR