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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SR 8 WITH PINPOINT GT ULTRASONIC PULSED ECHO IMAGING SYSTEM

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BARD ACCESS SYSTEMS SR 8 WITH PINPOINT GT ULTRASONIC PULSED ECHO IMAGING SYSTEM Back to Search Results
Model Number 9770501
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
Per biomed: sr 8 ultrasound systems w/pinpoint gt technology sn: (b)(4) is delayed in all functionality. Touchscreen and imaging is slow to respond. It was advised by fa that the biomed update the software from version 1. 0. 2 to 1. 0. 3 and see if the delay clears. Advised biomed to update fa with resolution.
 
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Brand NameSR 8 WITH PINPOINT GT
Type of DeviceULTRASONIC PULSED ECHO IMAGING SYSTEM
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
DYMAX CORP.
110 marshall drive
warrendale PA 15086
Manufacturer Contact
teresa johnson
605 n. 5600 w.
salt lake city, UT 84116
8015225435
MDR Report Key6877003
MDR Text Key87794308
Report Number3006260740-2017-01648
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 09/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9770501
Device Catalogue Number9770501
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
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? Yes
Type of Device Usage Reuse

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