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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC. 9T-D; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC. 9T-D; TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number 100121
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/24/2022
Event Type  malfunction  
Event Description
The ge 9t-d tee probe is delaminating even when it's put through a tee reprocessor for cleaning.A normal 9t-d probe go into a pt.And come out delaminated.
 
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Brand Name
9T-D
Type of Device
TRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC.
MDR Report Key18319060
MDR Text Key330477864
Report NumberMW5149181
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 12/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number100121
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/12/2023
Patient Sequence Number1
Patient Outcome(s) Other;
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