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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 Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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 Description
A customer reported an x7-2t model transducer had an articulation issue during use. There was no injury associated with this event.
 
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 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 Key7690552
MDR Text Key114154892
Report Number3019216-2018-00038
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030455
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number989605414121
Device Lot NumberB1JL9V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/02/2018
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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