MAUDE Adverse Event Report: DRAEGER B500 VENTILATOR

Model Number V500

Device Problems Defective Alarm (1014); Disconnection (1171)

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

Event Date 06/05/2017

Event Type  Injury  

Event Description

Pt's action caused et to become disconnected from vent tubing.Vent alarm did not sound for approx 2 min.

• Brand Name: B500 VENTILATOR
• Type of Device: B500 VENTILATOR
• Manufacturer (Section D): DRAEGER; irving TX 75063
• MDR Report Key: 6753639
• MDR Text Key: 81484925
• Report Number: MW5071283
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Life Threatening
• Patient Age: 56 YR
• Patient Weight: 56