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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC TRUWAVE; TRANSDUCER, PRESSURE, CATHETER TIP
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EDWARDS LIFESCIENCES LLC TRUWAVE; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number PX601
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2022
Event Type  malfunction  
Event Description
Becker external drainage and monitoring system leaking at the connection to transducer.
 
Event Description
Leaking is from edwards truwave transducer attached to becker external drainage and monitoring system.It leaks from around the cap on the end of the transducer.Issue noted with 7 devices over 3 month timeframe.No patient injury reported.Product info: truwave pressure transducers; edwards; ref px601; lot # unavailable.
 
Event Description
Leaking is from edwards truwave transducer attached to becker external drainage and monitoring system.It leaks from around the cap on the end of the transducer.Issue noted with 7 devices over 3 month timeframe.No patient injury reported.Product info: truwave pressure transducers; edwards; ref px601; lot # unavailable.
 
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Brand Name
TRUWAVE
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
EDWARDS LIFESCIENCES LLC
one edwards way
ms ss-54
irvine CA 92614
MDR Report Key16050598
MDR Text Key306178841
Report Number16050598
Device Sequence Number1
Product Code DXO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 12/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberPX601
Device Catalogue NumberPX601
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/16/2022
Event Location Hospital
Date Report to Manufacturer12/27/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/27/2022
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received01/27/2023
01/27/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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