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 HOTLINE LOW FLOW SYSTEM (HL-90); WARMER, THERMAL, INFUSION FLUID
  • 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 HOTLINE LOW FLOW SYSTEM (HL-90); WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-90
Device Problems Intermittent Continuity (1121); Electrical /Electronic Property Problem (1198)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
It was reported the level 1 hotline low flow system (hl-90) shuts down intermittently and starts up and continues this cycle.No patient injury or complications were reported in relation to this event.
 
Manufacturer Narrative
Other, other text: h10 ? device evaluation results: one level 1 hotline low flow system was returned for investigation in used condition.The tank cover was cracked.The unit also had an outdated pcb and power switch.The customer reported product problem (device shutting down intermittently) was reproduced during testing.This issue was occurring because the connection between the pcb and power switch was damaged.This was causing an intermittent power connection to the device.This product problem was attributed to a design flaw.This was established as the root cause.The unit was determined to be beyond economical repair due its old age.No repairs were made.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LEVEL 1 HOTLINE LOW FLOW SYSTEM (HL-90)
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10648494
MDR Text Key210398094
Report Number3012307300-2020-10232
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 11/20/2020
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 No Information
Device Model NumberHL-90
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/22/2020
Initial Date FDA Received10/08/2020
Supplement Dates Manufacturer Received10/23/2020
Supplement Dates FDA Received11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-