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: PHILIPS ULTRASOUND, INC EPIQ ELITE DIAGNOSTIC ULTRASOUND CHINA; 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
 

PHILIPS ULTRASOUND, INC EPIQ ELITE DIAGNOSTIC ULTRASOUND CHINA; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC Back to Search Results
Catalog Number 795236
Device Problem Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2022
Event Type  malfunction  
Event Description
The customer reported an that an ectopic pregnancy was not visualized on epiq elite ultrasound system but later confirmed on an mri and on a siemens ultrasound system.No patient or user was harmed as a result of the issue.An investigation is underway to determine the root cause of the issue.A follow up report will be provided upon investigation completion.
 
Event Description
The customer reported an that an ectopic pregnancy was not visualized on epiq elite ultrasound system but later confirmed on an mri and on a siemens ultrasound system.No patient or user was harmed as a result of the issue.An investigation is underway to determine the root cause of the issue.A follow up report will be provided upon investigation completion.
 
Manufacturer Narrative
The manufacturer previously reported the epiq elite ultrasound system was unable to visualize an ectopic pregnancy.No patient or user was harmed as a result of the issue.Multiple attempts to have additional information, images, and type of probe used were unsuccessful.The manufacturer believes they will be unable to gather any further information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
 
Manufacturer Narrative
An addendum report is being submitted to provide the date received by manufacturer with the philips¿ become aware date.The information is in the g3 field.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EPIQ ELITE DIAGNOSTIC ULTRASOUND CHINA
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 Key15976110
MDR Text Key307104419
Report Number3019216-2022-00114
Device Sequence Number1
Product Code IYN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K212704
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number795236
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/14/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/28/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
-
-