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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND EPIQ ELITE; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
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PHILIPS ULTRASOUND EPIQ ELITE; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC Back to Search Results
Model Number EPIQ ELITE ULTRASOUND SYSTEM
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2022
Event Type  malfunction  
Manufacturer Narrative
An investigation is underway to determine the root cause of the issue.Results of the investigation will be included in a follow up report upon its completion.
 
Event Description
A customer reported that there was an inaccurate display of the needle path during a biopsy with the 3d9-3v transducer on the epiq ultrasound system.The physician was able to complete the biopsy successfully without the use of the system.There was no patient or user harm as a result of the issue.
 
Manufacturer Narrative
A thorough investigation was performed to identify the root cause of the reported issue, including a technical and workflow evaluation of this event.The engineering team was unable to reproduce the issue as described by the customer.The needle guide aligned with the needle path displayed on the screen as designed during testing.The system is currently in use at the customer site with no additional similar issues reported.
 
Event Description
A customer reported that there was an inaccurate display of the needle path during a biopsy with the 3d9-3v transducer on the epiq ultrasound system.The physician was able to complete the biopsy successfully without the use of the system.There was no patient or user harm as a result of the issue.
 
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Brand Name
EPIQ ELITE
Type of Device
SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
Manufacturer (Section D)
PHILIPS ULTRASOUND
22100 bothell everett highway
bothell WA 98021
Manufacturer (Section G)
PHILIPS ULTRASOUND
22100 bothell everett highway
bothell WA 98021
Manufacturer Contact
eric nail
22100 bothell everett highway
bothell, WA 98021
MDR Report Key14704225
MDR Text Key294165574
Report Number3019216-2022-00060
Device Sequence Number1
Product Code IYN
UDI-Device Identifier00884838099111
UDI-Public00884838099111
Combination Product (y/n)N
Reporter Country CodeUS
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 Received06/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEPIQ ELITE ULTRASOUND SYSTEM
Device Catalogue Number795234
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2022
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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