• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL INC. TRANSPAC IV; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

  • 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
 

ICU MEDICAL INC. TRANSPAC IV; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR Back to Search Results
Lot Number 3166355
Device Problem Component Missing (2306)
Patient Problem No Information (3190)
Event Date 09/19/2016
Event Type  malfunction  
Event Description
Item opened onto a sterile field for use.It was noted that the wrong product tubing was in package.The transducer set inside this packaging is incorrect.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRANSPAC IV
Type of Device
TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL INC.
4455 atherton dr.
salt lake city UT 84123
MDR Report Key6092506
MDR Text Key59590251
Report Number6092506
Device Sequence Number1
Product Code DRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Lot Number3166355
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/26/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer09/26/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-