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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 05/17/2019
Event Type  Injury  
Manufacturer Narrative
A thorough inspection with functional and safety tests of the involved transducer was performed by the local philips service engineer. Proper functionality of the transducer was confirmed and the device remains at the customer site. Since a return of the transducer is not expected, no additional device analysis can be performed.
 
Event Description
A customer reported detecting a perforated esophagus after performing a transesophageal (tee) examination using an x7-2t model transducer with an epiq ultrasound system. The procedure was completed without any observed harm to the patient. The injury was noticed the next day, and the patient received treatment for the perforated esophagus. Further information regarding the patient condition post procedure was not disclosed and the device remains at the customer site.
 
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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 Key8717966
MDR Text Key148646746
Report Number3019216-2019-00031
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 Biomedical Engineer
Type of Report Initial
Report Date 05/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number989605414121
Device Lot NumberB1ZGZ6
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/24/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/23/2017
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: 06/20/2019 Patient Sequence Number: 1
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