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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIQ 7G; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
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EPIQ 7G; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC Back to Search Results
Model Number 989605386721
Device Problems Unintended System Motion (1430); Device Fell (4014)
Patient Problem Bruise/Contusion (1754)
Event Date 12/21/2020
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 an epiq 7g ultrasound system articulation arm assembly fell on a biomedical engineer during servicing.The biomedical engineer did not need medical treatment resulting from this event.Loose screws on the articulation arm assembly were tightened to resolve the immediate issue.
 
Manufacturer Narrative
An investigation determined that a previous field action addressed this system malfunction.This system was not on the initial units affected list (ual) for this issue, but has been subsequently added.A philips field service engineer implemented the field action by installing a control arm kit to resolve this problem.The ultrasound system has been placed back into service with no similar issues reported.This action was reported to fda per 21 cfr part 806 on march 17, 2016.Reference corrections and removal report number 3019216-03/17/2016-001-c.
 
Event Description
A customer reported an epiq 7g ultrasound system articulation arm assembly fell on a biomedical engineer during servicing.The biomedical engineer did not need medical treatment resulting from this event.Loose screws on the articulation arm assembly were tightened to resolve the immediate issue.
 
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Brand Name
EPIQ 7G
Type of Device
SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
MDR Report Key11096212
MDR Text Key224415608
Report Number3019216-2020-00129
Device Sequence Number1
Product Code IYN
UDI-Device Identifier00884838047693
UDI-Public00884838047693
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
Remedial Action Recall
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number989605386721
Device Catalogue Number795200
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date01/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number3019216-03-17-2016-001-C
Patient Sequence Number1
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