MAUDE Adverse Event Report: GE GE DINAMAP

Model Number PRO400V2

Device Problems Leak/Splash (1354); Device Emits Odor (1425)

Patient Problem No Information (3190)

Event Date 06/10/2017

Event Type  malfunction  

Event Description

Burning smell noted in the hallway in front of the nurses station.No smoke present.Burning smell coming from the vital sign machine in the hallway that is unplugged at that time.Lithium battery leakage noted and removed, placed on a separate bag and machine red tagged then placed on the supply room.

• Brand Name: GE DINAMAP
• Type of Device: DINAMAP
• Manufacturer (Section D): GE
• MDR Report Key: 6639588
• MDR Text Key: 77620751
• Report Number: MW5070391
• Device Sequence Number: 1
• Product Code: DXN
• 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: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRO400V2
• Was Device Available for Evaluation?: 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