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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 5 ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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BARD ACCESS SYSTEMS SITE~RITE 5 ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Catalog Number 9760107
Device Problem Loss of Power (1475)
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 unit losses power and easily shuts down.
 
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Brand NameSITE~RITE 5 ULTRASOUND SYSTEM
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
shelly gilbert
605 n. 5600 w.
salt lake city, UT 84116
8015225640
MDR Report Key8380503
MDR Text Key137799641
Report Number3006260740-2019-00433
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K052517
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 02/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9760107
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received02/08/2019
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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