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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE-RITE PREVUE PLUS; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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C.R. BARD, INC. (BASD) -3006260740 SITE-RITE PREVUE PLUS; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number N/A
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2023
Event Type  malfunction  
Event Description
The following was found during evaluation at bd service center: the prevue fails to charge and shuts off abruptly when disconnected from ac power.
 
Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling and applicable manufacture records.Based on a review of the information, the following was concluded: the device was returned to service facility for evaluation.During evaluation, the reported issue of the unit does not charge and shuts down was confirmed.The prevue fails to charge and shuts off abruptly when disconnected from ac power.The root cause is due to an internal failure within the lithium-ion battery.H3 other text : evaluation findings are in section h11.
 
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Brand Name
SITE-RITE PREVUE PLUS
Type of Device
SYSTEM, 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
johanna de oliveira
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key18139612
MDR Text Key328158853
Report Number3006260740-2023-05188
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741095450
UDI-Public(01)00801741095450
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120882
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/06/2023
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 Health Professional
Device Model NumberN/A
Device Catalogue Number9770086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/03/2023
Initial Date FDA Received11/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2019
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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