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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNER TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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BARD ACCESS SYSTEMS SITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNER TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Catalog Number 9763000
Device Problems Defective Device (2588); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device has not been received by the manufacturer, at this time, for evaluation. A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number. A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number. Device has not been received, at this time.
 
Event Description
It was reported that the equipment presents intermittent defect with freezing of the display and commands.
 
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Brand NameSITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNER
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
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
shelly gilbert
605 n. 5600 w.
salt lake city, UT 84116
8015225640
MDR Report Key8698341
MDR Text Key148162724
Report Number3006260740-2019-01660
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K052517
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9763000
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/20/2019
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

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