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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE / PHILIPS ULTRASOUND (SHANGHAI CO., LTD.) PHILIPS HEALTHCARE X5- 1 XMATRIX ARRAY TRANSDUCER WITH PUREWAVE CRYSTAL TECHNOLO TRANSDUCER ULTRASONIC DIAGNOSTIC

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PHILIPS HEALTHCARE / PHILIPS ULTRASOUND (SHANGHAI CO., LTD.) PHILIPS HEALTHCARE X5- 1 XMATRIX ARRAY TRANSDUCER WITH PUREWAVE CRYSTAL TECHNOLO TRANSDUCER ULTRASONIC DIAGNOSTIC Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
When using the philips x5-1 xmatrix array transducer with pure wave crystal technology with the philips ultrasound epiq 7c and epiq 5c, there have been failures with x5-1 xmatrix array transducer. Since the implantation of the x5-xmatrix array transducer, there have been roughly 15-17 failures. Products are exchange out. Fda safety report id# (b)(4).
 
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Brand NamePHILIPS HEALTHCARE X5- 1 XMATRIX ARRAY TRANSDUCER WITH PUREWAVE CRYSTAL TECHNOLO
Type of DeviceTRANSDUCER ULTRASONIC DIAGNOSTIC
Manufacturer (Section D)
PHILIPS HEALTHCARE / PHILIPS ULTRASOUND (SHANGHAI CO., LTD.)
MDR Report Key8631917
MDR Text Key145934718
Report NumberMW5086807
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 05/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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?
Type of Device Usage

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