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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Catalog Number 9770550
Device Problems Failure to Charge (1085); No Display/Image (1183); Battery Problem (2885)
Patient Problems No Patient Involvement (2645); 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 dyatad016 showed no other similar product complaint(s) from this serial number.
 
Event Description
It was reported: when the device is plugged in, it seems to work fine and the battery charges up to 100%.But once device is unplugged and should switch to battery power, the screen becomes black after a bit (less than 2 minutes).This reportedly happens without warning or without a normal switch off procedure.User reports not knowing if the device is switched off or in a "sleep mode." turning on the device only works when the device is plugged into power again, battery indicator reportedly still shows a fully charged battery.
 
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/servicing.During evaluation, the reported issue of the system's display going blank during use was confirmed.The root cause of the failure was identified as a faulty battery.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested, and returned to the customer.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: when the device is plugged in, it seems to work fine and the battery charges up to 100%.But once device is unplugged and should switch to battery power, the screen becomes black after a bit (less than 2 minutes).This reportedly happens without warning or without a normal switch off procedure.User reports not knowing if the device is switched off or in a "sleep mode." turning on the device only works when the device is plugged into power again, battery indicator reportedly still shows a fully charged battery.
 
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/servicing.During evaluation, the reported issue of the system's display going blank during use was confirmed.The root cause of the failure was identified as a faulty battery.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested, and returned to the customer.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: when the device is plugged in, it seems to work fine and the battery charges up to 100%.But once device is unplugged and should switch to battery power, the screen becomes black after a bit (less than 2 minutes).This reportedly happens without warning or without a normal switch off procedure.User reports not knowing if the device is switched off or in a "sleep mode." turning on the device only works when the device is plugged into power again, battery indicator reportedly still shows a fully charged battery.
 
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Brand Name
SITE~RITE 8 ULTRASOUND SYSTEM
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 Key8278425
MDR Text Key134251648
Report Number3006260740-2019-00085
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741098208
UDI-Public(01)00801741098208
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
Remedial Action Notification
Type of Report Initial,Followup,Followup
Report Date 11/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number9770550
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2019
Event Location Hospital
Date Manufacturer Received04/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number2243072-10/11/2019-013-C
Patient Sequence Number1
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