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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC TRANSDUCER X8-2T

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PHILIPS ULTRASOUND, INC TRANSDUCER X8-2T Back to Search Results
Model Number 989605455171
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The customer declined a replacement and the transducer remains at the user facility. Since the device was not returned, no failure analysis could be performed. The suspect transducer remains at the customer site with no return anticipated.
 
Event Description
A customer reported a loss of articulation with their x8-2t model transducer. There was no injury associated with this event.
 
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Brand NameTRANSDUCER X8-2T
Type of DeviceTRANSDUCER
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 Key9693960
MDR Text Key182632962
Report Number3019216-2020-00009
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K163120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 01/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number989605455171
Device Lot NumberB2JHZK
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/18/2018
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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