• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC X7-2T TRANSDUCER (MTEE) TRANSDUCER, ULTRASONIC, DIAGNOSTIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS ULTRASOUND, INC X7-2T TRANSDUCER (MTEE) TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number 989605414122
Device Problem Positioning Problem (3009)
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 articulation issue with their x7-2t model transducer. There was no injury associated with this event.
 
Manufacturer Narrative
Evaluation of the transducer concluded that insufficient solder was applied to one joint in the ferrule cylinder during the manufacturing process. Risk or impact of solder failure is mitigated by the current manufacturing process of performing additional testing at the factory to ensure proper articulation function. Assembly instructions have been refined and the re-training of assemblers has been implemented.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameX7-2T TRANSDUCER (MTEE)
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
paul corrigan
22100 bothell everett highway
bothell, WA 98021
4254877000
MDR Report Key7313431
MDR Text Key101657555
Report Number3019216-2018-00014
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeAS
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 02/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number989605414122
Device Lot NumberB25D6M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/28/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-