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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND EPIQ 7C; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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PHILIPS ULTRASOUND EPIQ 7C; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM
Device Problem Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2021
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 their epiq 7c ultrasound system would not offer the xplane functionality and the acquire button would not respond with an x8-2t transducer during a watchman mitral valve procedure.The system was exchanged for another epiq unit to complete the procedure and there was no allegation of altered patient outcome as a result of the issue.
 
Manufacturer Narrative
A thorough investigation was performed to identify the root cause of the reported issue.However, due to insufficient information able to be obtained, the engineering team was unable to determine the root cause of this failure.The system software was reloaded and the cables were reseated to resolve the issue for the customer.No additional similar issues have been reported since this repair.
 
Event Description
A customer reported their epiq 7c ultrasound system would not offer the xplane functionality and the acquire button would not respond with an x8-2t transducer during a watchman mitral valve procedure.The system was exchanged for another epiq unit to complete the procedure and there was no allegation of altered patient outcome as a result of the issue.
 
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Brand Name
EPIQ 7C
Type of Device
SYSTEM, IMAGING, PULSED ECHO, 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 Key12125686
MDR Text Key260468414
Report Number3019216-2021-10083
Device Sequence Number1
Product Code IYN
UDI-Device Identifier00884838097872
UDI-Public00884838097872
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 Received07/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM
Device Catalogue Number795201
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/08/2021
Date Manufacturer Received06/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2014
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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