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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE GE DINAMAP

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GE GE DINAMAP Back to Search Results
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.
 
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Brand NameGE DINAMAP
Type of DeviceDINAMAP
Manufacturer (Section D)
GE
MDR Report Key6639588
MDR Text Key77620751
Report NumberMW5070391
Device Sequence Number1
Product Code DXN
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received06/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRO400V2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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