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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770501
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/19/2018
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
It was reported by the service facility that there is interference in the bottom of the image box and the probe buttons function intermittently.
 
Event Description
It was reported by the service facility that there is interference in the bottom of the image box and the probe buttons function intermittently.
 
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 with no alleged deficiency.During evaluation, the service facility found the probe has poor image quality is confirmed.There is interference in the probe image box and the probe buttons intermittently function.The device was tested, serviced, and returned to refurbished inventory.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)(6) showed no other similar product complaint(s) from this serial number.
 
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Brand Name
SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED)
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 Key8242927
MDR Text Key133053142
Report Number3006260740-2019-00015
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 company representative
Type of Report Initial,Followup
Report Date 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9770501
Device Catalogue Number9770600Y
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2018
Event Location Hospital
Initial Date Manufacturer Received 12/19/2018
Initial Date FDA Received01/12/2019
Supplement Dates Manufacturer Received08/30/2019
Supplement Dates FDA Received08/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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