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: EXPRESSION INFORMATION PORTAL (IP5)
  • 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
 

EXPRESSION INFORMATION PORTAL (IP5) Back to Search Results
Model Number 865471
Medical Device Problem Code Incorrect Measurement (1383)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/01/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event or Problem Description
The customer contacted the customer care solution center and alleged that the complaint device made a siren-like sound and the power shut down.Additionally, the software was frozen.It is unknown if the complaint device was in clinical use at the time that the issue was discovered.
 
Event or Problem Description
It was reported that the complaint device made a siren-like wail, the power shut off and that the software was frozen.The device was in use on a patient.There was no report of patient or user harm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EXPRESSION INFORMATION PORTAL (IP5)
Common Device Name
EXPRESSION INFORMATION PORTAL (IP5)
MDR Report Key12513597
Report Number1051786-2021-10052
Device Sequence Number1100839
Product Code MWI
UDI-Device Identifier00884838031890
UDI-Public00884838031890
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K131382
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial 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
Operator of Device No Information
Device Model Number865471
Device Catalogue Number865471
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 09/01/2021
Supplement Date Received by Manufacturer09/01/2021
Initial Report FDA Received Date09/22/2021
Supplement Report FDA Received Date10/26/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
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
-
-