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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC TRANSDUCER X8-2T
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PHILIPS ULTRASOUND, INC TRANSDUCER X8-2T Back to Search Results
Model Number 989605455171
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
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 x8-2t model transducer had articulation control issues during use.The device was safely removed from the patient the procedure was completed successfully with another device with no negative patient outcome.There was no injury associated with this event.
 
Manufacturer Narrative
Evaluation of the x8-2t model transducer revealed damage to the connector, itube, and sensor.Performance testing found the transducer passed articulation and imaging tests.The physical damage to the transducer inhibited the overall performance of the device and is indicative of improper maintenance.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
TRANSDUCER X8-2T
Type of Device
TRANSDUCER
Manufacturer (Section D)
PHILIPS ULTRASOUND, INC
22100 bothell everett highway
bothell WA 98021
MDR Report Key10368630
MDR Text Key202776577
Report Number3019216-2020-00050
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K163120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number989605455171
Device Lot NumberB2XCLT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2020
Was the Report Sent to FDA? No
Date Manufacturer Received07/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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