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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE~RITE8 ULTRASOUND SYSTEM 20MM CUE LINEAR PROBE SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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C.R. BARD, INC. (BASD) -3006260740 SITE~RITE8 ULTRASOUND SYSTEM 20MM CUE LINEAR PROBE SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770603
Device Problems Image Display Error/Artifact (1304); Defective Component (2292)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2021
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will be evaluated. A supplemental will be submitted with evaluation results. A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
 
Event Description
Per biomed - black mark in the center of the screen that impairs vision.
 
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Brand NameSITE~RITE8 ULTRASOUND SYSTEM 20MM CUE LINEAR PROBE
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
DYMAX CORP. -2523003
110 marshall drive
warrendale PA 15086
Manufacturer Contact
shelly gilbert
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key11322837
MDR Text Key233327779
Report Number3006260740-2021-00335
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9770603
Device Catalogue Number9770603
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2021
Was Device Evaluated by Manufacturer? Yes
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: 02/12/2021 Patient Sequence Number: 1
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