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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIQ 7C ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
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EPIQ 7C ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC Back to Search Results
Model Number EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM
Device Problem Erratic or Intermittent Display (1182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2021
Event Type  malfunction  
Manufacturer Narrative
Return of the suspect transducer is anticipated.Evaluation of the transducer will be included in a follow-up report upon its return and investigation completion.
 
Event Description
A customer reported an x7-2t model transducer on an epiq 7c ultrasound system was producing flashing images during a transesophageal echocardiogram (tee) examination for a cardiac ablation procedure.The customer was able to obtain enough information to complete the procedure.No patient or user was harmed as a result of the issue.
 
Event Description
A customer reported an x7-2t model transducer on an epiq 7c ultrasound system was producing flashing images during a transesophageal echocardiogram (tee) examination for a cardiac ablation procedure.The customer was able to obtain enough information to complete the procedure.No patient or user was harmed as a result of the issue.
 
Manufacturer Narrative
A philips service engineer replaced the involved transducer on the ultrasound system.Evaluation of the suspect transducer was performed upon its return from the customer.Evaluation of the transducer confirmed the imaging issue as described by the customer.Functional testing of the device noted failure of the image, chip, and pulse echo tests.Visual inspection noted a hole in the sheath, bite damage to the tipshell and edge of the window, and scratches on the i-tube.The physical damage to the transducer inhibited the overall performance of the device and is indicative of improper maintenance.
 
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Brand Name
EPIQ 7C ULTRASOUND SYSTEM
Type of Device
SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
MDR Report Key12194960
MDR Text Key262425235
Report Number3019216-2021-10089
Device Sequence Number1
Product Code IYN
UDI-Device Identifier00884838097872
UDI-Public00884838097872
Combination Product (y/n)N
PMA/PMN Number
K132304
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
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
Device Lot NumberUSO13B0461
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date06/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2014
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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