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: ST PAUL LEVEL 1; SYSTEM, THERMAL REGULATING
  • 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
 

ST PAUL LEVEL 1; SYSTEM, THERMAL REGULATING Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Other, other text: one level 1 equator blower was returned for analysis.The enclosure was found old and dirty with label residue and scuff marks.Air filter was dirty.The reported issue was confirmed and the device was found out of specification.No action was taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.
 
Event Description
Information was received indicating that the level 1 equator blower temperature was out of specification.There were no adverse events reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LEVEL 1
Type of Device
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
1325 spring st
minneapolis, MN 55442
MDR Report Key10093924
MDR Text Key192258137
Report Number3012307300-2020-04511
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2019
Was the Report Sent to FDA? No
Date Manufacturer Received03/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-