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

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; EXTRAVASCULAR BLOOD FLOW PROBE

  • 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 MEDICAL ASD, INC. MEDEX; EXTRAVASCULAR BLOOD FLOW PROBE Back to Search Results
Model Number MX9505T
Device Problem Pressure Problem (3012)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/04/2021
Event Type  malfunction  
Event Description
It was reported that the pressure values are not displayed.
 
Event Description
Lot number provided does not correspond to reporting manufacturer lot number format and could not be verified.
 
Manufacturer Narrative
No verifiable lot or serial number was provided; therefore, device history record review could not be performed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.H4: device manufacturing date and d4: device expiration date could not be determined.Patient information updated (b2, b3), corrected data: report source updated (g3), h6 event problem code updated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MEDEX
Type of Device
EXTRAVASCULAR BLOOD FLOW PROBE
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6250 shier rings road
dublin OH 43016
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6250 shier rings road
dublin OH 43016
Manufacturer Contact
jim vegel
6000 nathan lane north
binhu district
minneapolis, MN 55442
MDR Report Key12418255
MDR Text Key269758054
Report Number3012307300-2021-09121
Device Sequence Number1
Product Code DPT
UDI-Device Identifier10351688503992
UDI-Public10351688503992
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 Other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/07/2022
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 Model NumberMX9505T
Device Lot Number20210208
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/04/2021
Initial Date FDA Received09/02/2021
Supplement Dates Manufacturer Received08/10/2022
Supplement Dates FDA Received09/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age61 YR
Patient SexMale
-
-