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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CUSTOM DEFINED DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE, CATHETER TIP
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EDWARDS LIFESCIENCES DR CUSTOM DEFINED DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number T100671B
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 12/01/2014
Event Type  malfunction  
Event Description
It was reported that there was a zeroing deviance of the arterial pressure during use.The patient was treated for hypertension that consequently lead to hypotension.The dpt was exchanged for another and the issue was corrected.
 
Manufacturer Narrative
The device evaluation is anticipated.However, the complaint could not be confirmed without the completion of the product evaluation.A supplemental report will be sent when the investigation and device history record are complete.
 
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Brand Name
CUSTOM DEFINED DISPOSABLE PRESSURE TRANSDUCER
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
EDWARDS LIFESCIENCES DR
parque industrial de itabo
carr. sanchez km 18.5
haina, san cristobal
DR 
Manufacturer (Section G)
EDWARDS LIFESCIENCES DR
parque industrial de itabo
carr. sanchez km 18.5
haina, san cristobal
DR  
Manufacturer Contact
lynn selawski
1 edwards way
irvine, CA 92614
9497564386
MDR Report Key4359005
MDR Text Key17260085
Report Number2015691-2014-03129
Device Sequence Number1
Product Code DXO
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberT100671B
Device Lot Number59790475
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/02/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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