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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ CVX; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
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PHILIPS ULTRASOUND, INC EPIQ CVX; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC Back to Search Results
Model Number EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
Device Problems Computer Software Problem (1112); Operating System Becomes Nonfunctional (2996)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2021
Event Type  malfunction  
Event Description
A customer reported their epiq cvx ultrasound system shut down with an error message during use on a high risk patient.The procedure in progress was completed successfully using a different ultrasound system available at the customer site.There was no allegation of altered patient outcome as a result of the issue.
 
Manufacturer Narrative
A philips service engineer is scheduled to retrieve the system logs at the customer site.Evaluation of the logs will be included in a follow up report upon investigation completion.
 
Event Description
A customer reported their epiq cvx ultrasound system shut down with an error message during use on a high risk patient.The procedure in progress was completed successfully using a different ultrasound system available at the customer site.There was no allegation of altered patient outcome as a result of the issue.
 
Manufacturer Narrative
A thorough investigation of the event was to be performed; however, no system logs were received and are not expected to be received.The engineer reloaded the software and was unable to duplicate the failure.The system is back in clinical use at the user¿s facility.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
 
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Brand Name
EPIQ CVX
Type of Device
SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
Manufacturer (Section D)
PHILIPS ULTRASOUND, INC
22100 bothell everett highway
bothell WA 98021
Manufacturer (Section G)
PHILIPS ULTRASOUND, INC
22100 bothell everett highway
bothell WA 98021
Manufacturer Contact
thuy nguyen
22100 bothell everett highway
bothell, WA 98021
MDR Report Key13142384
MDR Text Key283094926
Report Number3019216-2022-00001
Device Sequence Number1
Product Code IYN
UDI-Device Identifier00884838097933
UDI-Public00884838097933
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K132304
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEPIQ DIAGNOSTIC ULTRASOUND SYSTEM
Device Catalogue Number795231
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/25/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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