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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL INC. DRAEGER BP MONITOR INFINITY M540

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DRAEGER MEDICAL INC. DRAEGER BP MONITOR INFINITY M540 Back to Search Results
Model Number INFINITY 540
Device Problems Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/15/2016
Event Type  malfunction  
Event Description
A 540 blood pressure failed and would not give a reading during a procedure. The m540 was taken out of service. M540 was replaced with a functioning "loaner" unit.
 
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Brand NameDRAEGER BP MONITOR INFINITY M540
Type of DeviceBP MONITOR INFINITY M540
Manufacturer (Section D)
DRAEGER MEDICAL INC.
telford PA 18969
MDR Report Key5900577
MDR Text Key52969944
Report NumberMW5064291
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 08/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberINFINITY 540
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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