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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC TRANSDUCER X7-2T ULTRASOUND

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PHILIPS ULTRASOUND, INC TRANSDUCER X7-2T ULTRASOUND Back to Search Results
Model Number 989605414121
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
 
Event Description
A customer reported encountering an articulation issue with their x7-2t model transducer during a surgical procedure. There was no injury associated with this event.
 
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Brand NameTRANSDUCER X7-2T
Type of DeviceULTRASOUND
Manufacturer (Section D)
PHILIPS ULTRASOUND, INC
22100 bothell everett highway
bothell WA 98021
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
paul corrigan
22100 bothell everett highway
bothell, WA 98021
4254877000
MDR Report Key10089474
MDR Text Key193131362
Report Number3019216-2020-00029
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K030455
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number989605414121
Device Lot NumberB1GY4J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/11/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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