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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770602
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/04/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been received by the manufacturer for evaluation. A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
 
Event Description
Per tm - image on screen is distorted.
 
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Brand NameSITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
MDR Report Key11251093
MDR Text Key230341647
Report Number3006260740-2021-00120
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
PMA/PMN Number
K152554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial
Report Date 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9770602
Device Catalogue Number9770602
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/29/2021 Patient Sequence Number: 1
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