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: AFFINITI 50; SYSTEM, IMAGING, PULSED ECHO, 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
 

AFFINITI 50; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number AFFINITI 50 ULTRASOUND SYSTEM
Medical Device Problem Code Patient Data Problem (3197)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/11/2021
Type of Reportable Event Malfunction
Additional 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 or Problem Description
A customer reported after sending a study to pacs from their affiniti 50 ultrasound system, it had subsequently merged with another patient¿s study.The issue was identified by the user and there was no allegation of altered patient outcome as a result of the issue.
 
Additional Manufacturer Narrative
A thorough investigation was performed to identify the root cause of this reported issue.Evaluation of the system logs found no errors, and it was concluded that there was no system malfunction associated with this event.The investigation determined the issue was caused by a problem with the customer¿s non-philips pacs system.The system is in use at the customer facility with no additional issues reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AFFINITI 50
Common Device Name
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
MDR Report Key11286829
Report Number3019216-2021-10000
Device Sequence Number11631715
Product Code IYN
UDI-Device Identifier00884838056244
UDI-Public00884838056244
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K132304
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
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
Operator of Device Health Professional
Device Model NumberAFFINITI 50 ULTRASOUND SYSTEM
Device Catalogue Number795208
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date01/11/2021
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date02/05/2021
Supplement Report FDA Received Date05/12/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured06/03/2017
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Reuse
Patient Sequence Number1
-
-