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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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PHILIPS ULTRASOUND, INC TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Lot Number B1J1PW
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 05/19/2017
Event Type  Injury  
Manufacturer Narrative
A thorough inspection and functional and safety test of the involved transducer was performed by the local philips service engineer. Proper functionality of the transducer was confirmed and the device remains in use at the customer site. No additional device analysis is expected. No transducer malfunction was alleged.
 
Event Description
A customer reported detecting a perforated esophagus while performing an examination using an x7-2t model transducer with a cx50 ultrasound system. Further information regarding the patient condition was not disclosed.
 
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Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
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
tara mackinnon
22100 bothell everett highway
bothell, WA 98021
4254877000
MDR Report Key6595178
MDR Text Key76084719
Report Number3019216-2017-00014
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 Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 05/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberB1J1PW
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 Received05/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/16/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/26/2017 Patient Sequence Number: 1
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