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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SITE~RITE PREVUE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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SITE~RITE PREVUE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770090
Medical Device Problem Code No Display/Image (1183)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional 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: during evaluation, it was found the system displays dark vertical lines in the probe image.The device was serviced, tested, and returned to the customer.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
 
Event or Problem Description
During evaluation, it was found the system displays dark vertical lines in the probe image.
 
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Brand Name
SITE~RITE PREVUE
Common Device Name
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
MDR Report Key10218692
Report Number3006260740-2020-02315
Device Sequence Number2107987
Product Code IYO
UDI-Device Identifier00801741091056
UDI-Public(01)00801741091056
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K120882
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 07/01/2020
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
Operator of Device Health Professional
Device Model Number9770090
Device Catalogue Number9770090
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2020
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/13/2020
Initial Report FDA Received Date07/01/2020
Was Device Evaluated by Manufacturer? (Y/N) Yes
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Reuse
Patient Sequence Number1
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