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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770602Y
Medical Device Problem Code Poor Quality Image (1408)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/06/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device will not be returned to the manufacturer for evaluation, as the device is being retained by the reporting facility.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
 
Event or Problem Description
Per tm - customer is reporting a raining interference in the lower third of the image.
 
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Brand Name
SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT
Common Device Name
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
MDR Report Key12681363
Report Number3006260740-2021-04437
Device Sequence Number1364251
Product Code IYO
UDI-Device Identifier00801741138201
UDI-Public(01)00801741138201
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K152554
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/08/2021
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 Number9770602Y
Device Catalogue Number9770602Y
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/06/2021
Initial Report FDA Received Date10/22/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
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
Outcome Attributed to Adverse Event Other;
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