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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 Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
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 x7-2t model transducer revealed corrosion on the connector and between the knobs on the midhandle. Performance testing of the probe verified proper function of the articulation knobs, so the reported problem could not be confirmed. However, signs of corrosion or material buildup were identified within the knob/midhandle interface which may have led to the issue observed in the field. The investigation concluded that exposure to fluid and materials over time likely resulted in the buildup and reported problem. The damage found on the probe is indicative of improper transducer care and maintenance.
 
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Brand NameTRANSDUCER X7-2T
Type of DeviceULTRASOUND
Manufacturer (Section D)
PHILIPS ULTRASOUND, INC
22100 bothell everett highway
bothell WA 98021
MDR Report Key7912265
MDR Text Key122006629
Report Number3019216-2018-00047
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K030455
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 08/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number989605414121
Device Lot NumberB238TX
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/12/2018
Is This a Reprocessed and Reused Single-Use Device? No

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