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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE~RITE HALCYON ULTRASOUND SYSTEM; DIAGNOSTIC ULTRASOUND SYSTEM

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C.R. BARD, INC. (BASD) -3006260740 SITE~RITE HALCYON ULTRASOUND SYSTEM; DIAGNOSTIC ULTRASOUND SYSTEM Back to Search Results
Catalog Number 950041600
Device Problem Data Problem (3196)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been received by the manufacturer for evaluation.A history review of serial number 119121267 showed four other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
 
Event Description
Per biomed - kept giving negative deflection far from the sa node and caused them to get a chest x-rays.Happening with 4-5 different patients.This is for the second of five reported events.
 
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Brand Name
SITE~RITE HALCYON ULTRASOUND SYSTEM
Type of Device
DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer Contact
shelly gilbert
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key11610557
MDR Text Key243857077
Report Number3006260740-2021-01128
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170870
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
Report Date 03/30/2021
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 Health Professional
Device Catalogue Number950041600
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/08/2021
Initial Date FDA Received04/02/2021
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 Sequence Number1
Patient Outcome(s) Other;
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