Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIQ 7; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

EPIQ 7; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC Back to Search Results
Model Number EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM
Device Problem Unintended System Motion (1430)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2021
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
The customer reported an incident where the swivel mechanism of their epiq ultrasound system¿s control panel would not lock into position while transporting the unit within the user facility.The failure occurred outside of clinical use and no patient or user was harmed as a result of the issue.The ultrasound system has been returned to service with no additional issues reported.
 
Manufacturer Narrative
A thorough investigation was performed to identify the root cause of the reported issue.The engineering team determined the failure was caused by a hardware issue in the articulating arm latching mechanism preventing the locking solenoid from fully engaging.Additional actions to prevent this failure from occurring are underway.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EPIQ 7
Type of Device
SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
MDR Report Key11346039
MDR Text Key232537441
Report Number3019216-2021-10019
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 Received02/18/2021
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
Distributor Facility Aware Date02/11/2021
Date Manufacturer Received02/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-