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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS REFURB, SR PREVUE PLUS SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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BARD ACCESS SYSTEMS REFURB, SR PREVUE PLUS SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number N/A
Device Problems Failure to Charge (1085); Smoking (1585)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard 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 bard. The manufacturer has received the sample and will be evaluated. Results are expected soon. A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
 
Event Description
Biomed reported system has smoke coming out of the ac port and fails to charge. System reportedly will not turn on.
 
Manufacturer Narrative
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 this information, the following was concluded: during evaluation, the reported issue of the system failing to charge and smoke coming from the system was confirmed. Although the unit was not observed to be smoking, the ac input on the prevue+ unit was found to be burned and melted on the motherboard. The beamformer also was found to have black burned marks and the lithium ion battery had a burned hole on one side. The power supply provided by the customer also had power plug damage. The root cause of the system smoking and failing to charge was identified as a damaged power supply plug. No other issues with the equipment were found during evaluation. The ac adapter was replaced and the prevue+ was serviced, qc tested, and returned to the customer. A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
 
Event Description
Biomed reported system has smoke coming out of the ac port and fails to charge. System reportedly will not turn on.
 
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Brand NameREFURB, SR PREVUE PLUS
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
DYMAX CORP.
141 zehner school road
zelienople PA 16063
Manufacturer Contact
shelly gilbert
605 n. 5600 w.
salt lake city, UT 84116
8015225640
MDR Report Key7692420
MDR Text Key114230552
Report Number3006260740-2018-01730
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741124945
UDI-Public(01)00801741124945
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 user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number9770086R
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received08/06/2019
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

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