MAUDE Adverse Event Report: DRAEGER DRAGER; BABY LOG

Model Number VN500

Device Problems Device Alarm System (1012); Device Emits Odor (1425); Battery Problem (2885)

Patient Problem No Information (3190)

Event Date 10/05/2016

Event Type  malfunction  

Event Description

Infant on drager ventilator and crisis alarmed battery activated.Rn was at bedside at time.Respiratory therapy was called immediately and baby was taken off the ventilator.Drager ventilator was noted to have a burn smell coming from it.Ventilator was found to be running on battery and ventilator was switched out.

• Brand Name: DRAGER
• Type of Device: BABY LOG
• Manufacturer (Section D): DRAEGER; 3135 quarry rd; telford PA 18969
• MDR Report Key: 6078519
• MDR Text Key: 59356500
• Report Number: MW5065806
• Device Sequence Number: 1
• Product Code: CBK
• 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: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VN500
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 DA
• Patient Weight: 1