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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ 7C ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
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PHILIPS ULTRASOUND, INC EPIQ 7C ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC Back to Search Results
Model Number EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM
Device Problems No Device Output (1435); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2021
Event Type  malfunction  
Manufacturer Narrative
A philips service engineer swapped the system¿s dimms (dual in-line memory modules) to resolve the immediate issue.System logs have been returned for evaluation.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 an epiq 7c ultrasound system became unresponsive and proceeded to shut down during a cardiac procedure.However, the procedure in progress was completed successfully without the use of the ultrasound system.There was no patient or user harm associated with this event.
 
Manufacturer Narrative
A technical investigation was performed.The philips service engineer evaluated the system in the field and confirmed the system would not complete booting up.The system logs were received and reviewed.There was no information from the logs as to the root cause of the failure.Troubleshooting of the dimm memory was conducted, reseating the dimm memory cards resolved the issue.The system was able to boot normally and passed hardware and performance functional testing.The system left at the customer site functioning normally.
 
Event Description
A customer reported an epiq 7c ultrasound system became unresponsive and proceeded to shut down during a cardiac procedure.However, the procedure in progress was completed successfully without the use of the ultrasound system.There was no patient or user harm associated with this event.
 
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Brand Name
EPIQ 7C ULTRASOUND SYSTEM
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 Key12741174
MDR Text Key279810482
Report Number3019216-2021-10139
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 Received11/02/2021
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
Date Manufacturer Received10/13/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/30/2017
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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