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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 Problems Failure to Charge (1085); Loss of Power (1475); Battery Problem (2885)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device has not been received by the manufacturer, at this time, for evaluation.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 battery is not keeping a charge.The battery appears to take a charge but it will shut down during a procedure even if the battery life says 60-70% when unplugged.If left plugged in it will not shut down when in use.
 
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 the battery will not hold a charge is confirmed.The root cause of the reported issue is an internal battery failure.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 tm: the battery is not keeping a charge.The battery appears to take a charge but it will shut down during a procedure even if the battery life says 60-70% when unplugged.If left plugged in it will not shut down when in use.
 
Event Description
Per tm: the battery is not keeping a charge.The battery appears to take a charge but it will shut down during a procedure even if the battery life says 60-70% when unplugged.If left plugged in it will not shut down when in use.
 
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 the battery will not hold a charge is confirmed.The root cause of the reported issue is an internal battery failure.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.
 
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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 Key8341784
MDR Text Key136249722
Report Number3006260740-2019-00276
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
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
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 Manufacturer03/20/2019
Event Location Hospital
Initial Date Manufacturer Received 01/22/2019
Initial Date FDA Received02/14/2019
Supplement Dates Manufacturer Received05/15/2019
10/11/2019
Supplement Dates FDA Received06/12/2019
11/04/2019
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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