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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
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Return of the suspect transducer is anticipated.Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
 
Event or Problem Description
A customer reported an x7-2t model transducer had an articulation issue during use.There was no injury associated with this event.
 
Additional Manufacturer Narrative
Evaluation of the transducer could not duplicate the articulation issue as described by the customer.Investigation of the device noted all diagnostic and performance testing passed without failures.
 
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Brand Name
TRANSDUCER X7-2T
Common Device Name
ULTRASOUND
Manufacturer (Section D)
PHILIPS ULTRASOUND, INC
22100 bothell everett highway
bothell WA 98021
MDR Report Key7690552
Report Number3019216-2018-00038
Device Sequence Number11011897
Product Code ITX
UDI-Device Identifier00884838061668
UDI-Public(01)00884838061668
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K030455
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 06/22/2018
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
Operator of Device Health Professional
Device Model Number989605414121
Device Lot NumberB1JL9V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2018
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 06/22/2018
Supplement Date Received by Manufacturer06/22/2018
Initial Report FDA Received Date07/16/2018
Supplement Report FDA Received Date08/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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