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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770600
Device Problem Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2020
Event Type  malfunction  
Manufacturer Narrative
The device has not been received by the manufacturer for evaluation.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.Device not returned for evaluation.
 
Event Description
Per director of nursing scanner keeps freezing within 10 seconds every time it is turned on.They tried resetting but still freezes.
 
Event Description
Per director of nursing scanner keeps freezing within 10 seconds every time it is turned on.They tried resetting but still freezes.
 
Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.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 scanner keeps freezing within 10 seconds every time it is turned on was confirmed; the probe would freeze when scanning after 5 minutes.The scanner would still function normally, but could not scan.The root cause of the reported failure was identified as the beamformer board would cause the scanning to freeze.A history review of serial number dyczac503 showed no other similar product complaint(s) from this serial number.H3 other text : evaluation findings are in section h.11.
 
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Brand Name
SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR
Type of Device
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
MDR Report Key10836392
MDR Text Key217675458
Report Number3006260740-2020-20520
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741138263
UDI-Public(01)00801741138263
Combination Product (y/n)N
PMA/PMN Number
K152554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 04/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9770600
Device Catalogue Number9770600
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2020
Date Manufacturer Received04/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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