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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 9770500
Device Problems Battery Problem (2885); Power Problem (3010)
Patient Problems No Consequences Or Impact To Patient (2199); 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 biomed: the machine is plugged into wall power, the machine turns on and functions as normal.However, the top left power icon is green and the battery icon is flashing red.The switch on the back of the unit is in the up position and the battery icon still is flashing.The unit is at 100% battery life but when the power supply is remove the machine immediately shuts off.
 
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 unit not holding a charge was confirmed.During evaluation the scanner was fully charged once the ac adaptor was disconnected the unit shut down, the cause of the issue is an internal failure in the lithium-ion battery causing the premature discharge of the 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 dyarac024 showed no other similar product complaint(s) from this serial number.
 
Event Description
Per biomed: the machine is plugged into wall power, the machine turns on and functions as normal.However, the top left power icon is green and the battery icon is flashing red.The switch on the back of the unit is in the up position and the battery icon still is flashing.The unit is at 100% battery life but when the power supply is remove the machine immediately shuts off.
 
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 unit not holding a charge was confirmed.During evaluation the scanner was fully charged once the ac adaptor was disconnected the unit shut down, the cause of the issue is an internal failure in the lithium-ion battery causing the premature discharge of the 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
Per biomed: the machine is plugged into wall power, the machine turns on and functions as normal.However, the top left power icon is green and the battery icon is flashing red.The switch on the back of the unit is in the up position and the battery icon still is flashing.The unit is at 100% battery life but when the power supply is remove the machine immediately shuts off.
 
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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 Key8324034
MDR Text Key136026610
Report Number3006260740-2019-00218
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741096891
UDI-Public(01)00801741096891
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
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 Received02/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9770500
Device Catalogue Number9770500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2019
Event Location Hospital
Date Manufacturer Received10/11/2019
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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