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

MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX TRANSTAR TRANSDUCER SINGLE MONITORING KIT; PROBE, BLOOD-FLOW, 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
 

SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX TRANSTAR TRANSDUCER SINGLE MONITORING KIT; PROBE, BLOOD-FLOW, EXTRAVASCULAR Back to Search Results
Catalog Number MX9505T
Device Problems Unable to Obtain Readings (1516); Failure to Recalibrate (1517)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/03/2024
Event Type  malfunction  
Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported that while preparing to use a pressure sensor to monitor central venous pressure, it was found that the monitor had no normal waveform after the pressure sensor was connected to the lead wire.At the same time, it could also not be adjusted to zero.The same problem occurred after replacing the lead wire multiple times, but eventually the display showed up normally.There was no patient involvement and no harm/adverse event reported.
 
Manufacturer Narrative
One device was received for investigation.The device was functionally tested.During the testing, the device failed the electrical test.The reported complaint is confirmed.The main electrical board was damaged, and the pressure sensor is faulty.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MEDEX TRANSTAR TRANSDUCER SINGLE MONITORING KIT
Type of Device
PROBE, BLOOD-FLOW, EXTRAVASCULAR
Manufacturer (Section D)
SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
carretera miguel alemán km21.7
apodaca nuevo leon
MX 
Manufacturer Contact
reed covert
6000 nathan lane north
minneapolis, MN 55442
2247062300
MDR Report Key18595895
MDR Text Key333969092
Report Number9616567-2024-00018
Device Sequence Number1
Product Code DPT
UDI-Device Identifier10351688503992
UDI-Public(01)10351688503992(17)250905(10)4323153
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K942377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/19/2024
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 Other
Device Catalogue NumberMX9505T
Device Lot Number4323153
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/11/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/03/2024
Initial Date FDA Received01/29/2024
Supplement Dates Manufacturer Received02/22/2024
Supplement Dates FDA Received03/19/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-