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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. SITE~RITE 8 ULTRASOUND SYSTEM SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

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BARD ACCESS SYSTEMS, INC. SITE~RITE 8 ULTRASOUND SYSTEM SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Catalog Number 9770600
Device Problems Battery Problem (2885); Unexpected Shutdown (4019)
Patient Problem Insufficient Information (4580)
Event Date 03/22/2021
Event Type  malfunction  
Event Description
Ivus machine not holding a charge or working while plugged in. Biomed was called yesterday to help trouble shoot. Machine has been plugged into 3 different outlets all day; writer pushed in all connections to electrical pack. Machine powers on, red battery light flashes, and when machine turns on, it immediately counts down and shuts off.
 
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Brand NameSITE~RITE 8 ULTRASOUND SYSTEM
Type of DeviceSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key11669516
MDR Text Key245525431
Report Number11669516
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9770600
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/24/2021
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer04/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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