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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE PREVUE+ ULTRASOUND SYSTEM REFURB SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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BARD ACCESS SYSTEMS SITE~RITE PREVUE+ ULTRASOUND SYSTEM REFURB SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Catalog Number 9770086R
Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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
Per biomed: sr prevue+ sn: (b)(4) has a damaged probe strain relief and the system intermittently "locks up" and the system needs to be restarted to get it to function again.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, 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: the complaint of the prevue+ system freezing was inconclusive because the clinical setting nor the reported issue could be reproduced. The equipment was returned and assessed by the manufacture site. The manufacture site reported that the scanner passed functional testing requirements. Reference cesc rec (b)(4) for complete evaluation and servicing details. The returned system did not display the behavior reported by the complainant and it is likely that the event was caused by another root cause. A history review of serial number dyybq049 showed no other similar complaint(s) from this serial number.
 
Event Description
Per biomed: sr prevue+ sn: (b)(4) has a damaged probe strain relief and the system intermittently "locks up" and the system needs to be restarted to get it to function again.
 
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Brand NameSITE~RITE PREVUE+ ULTRASOUND SYSTEM REFURB
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. -2523003
110 marshall drive
warrendale PA 15086
Manufacturer Contact
sydney freckleton
605 n. 5600 w.
salt lake city, UT 84116
8015225992
MDR Report Key7322418
MDR Text Key101973816
Report Number3006260740-2018-00393
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150529
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 05/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9770086R
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received04/13/2018
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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