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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770501
Device Problem Signal Artifact/Noise (1036)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will be evaluated.Results are expected soon.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.
 
Event Description
Per tm: the unit has interference/artifact issues with sherlock when plugged in power.
 
Event Description
Per tm: the unit has interference/artifact issues with sherlock when plugged in power.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, 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 device was returned to the service facility for evaluation.During evaluation, the reported issue of interference/artifact issues with sherlock was unconfirmed.The customer sherlock display an internal ekg when connected both the yellow and white lines are present.The customer sherlock was tested in every usb port with the ac adapter connected and once without the ac adapter both times the sherlock operated normally with no visual errors noted.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.The device was serviced, tested, and returned to the customer.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.
 
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Brand Name
SITE-RITE 8 ULTRASOUND
Type of Device
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8566669
MDR Text Key143816400
Report Number3006260740-2019-01223
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741098338
UDI-Public(01)00801741098338
Combination Product (y/n)N
PMA/PMN Number
K152554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9770501
Device Catalogue Number9770501
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2019
Event Location Hospital
Date Manufacturer Received07/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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