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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DYMAX CORP. -2523003 SITE-RITE 8 ULTRASOUND ULTRASONIC PULSED ECHO IMAGING SYSTEM

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DYMAX CORP. -2523003 SITE-RITE 8 ULTRASOUND ULTRASONIC PULSED ECHO IMAGING SYSTEM Back to Search Results
Model Number 9770501
Device Problems Device Stops Intermittently (1599); Connection Problem (2900)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, 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 service facility confirmed that the ultrasound image intermittently lags after the scanner is powered-on. During evaluation, it was found that the ultrasound image lag was caused by computer software issues, although it could not be determined what in the computer software was causing the image delay. A lot history review of serial number (b)(4) showed no other similar product complaint(s) from this lot number.
 
Event Description
Per biomed: sr 8 w/pinpoint gt technology sn: (b)(4) intermittently has a 1+ second lag in the live ultrasound image. System is running sw ver 1. 0. 3 and is being used in image filter 3. System is not connected to the network for pacs, no flash drive or printer is attached.
 
Manufacturer Narrative
The information provided by bard 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 bard. The device has not been returned to the manufacturer, at this time, for evaluation. A lot history review (lhr) of dyatac031 showed no other similar product complaint(s) from this lot number.
 
Event Description
Per biomed: sr 8 w/pinpoint gt technology sn: dyatac031 intermittently has a 1+ second lag in the live ultrasound image. System is running sw ver 1. 0. 3 and is being used in image filter 3. System is not connected to the network for pacs, no flash drive or printer is attached.
 
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Brand NameSITE-RITE 8 ULTRASOUND
Type of DeviceULTRASONIC PULSED ECHO IMAGING SYSTEM
Manufacturer (Section D)
DYMAX CORP. -2523003
110 marshall drive
warrendale PA 15086
Manufacturer (Section G)
DYMAX CORP. -2523003
110 marshall drive
warrendale PA 15086
Manufacturer Contact
shelly gilbert
605 n. 5600 w.
salt lake city, UT 84116
8015225640
MDR Report Key7026070
MDR Text Key188120638
Report Number3006260740-2017-02022
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741098338
UDI-Public(01)00801741098338
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9770501
Device Catalogue Number9770501
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/11/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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