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

MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE 290 FLUID WARMING DEVICE; 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
 

OAKDALE LEVEL 1 HOTLINE 290 FLUID WARMING DEVICE; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-290
Device Problems Insufficient Heating (1287); Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2021
Event Type  malfunction  
Event Description
It was reported the device "broke down".No adverse effects reported.
 
Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.The device was unpacked, the tank was filled with water and the disposable was attached.But after the start button was pressed audio alarm came one and the device didn't work.After opening the device was discovered that the water sensor assembly was defective.The root cause of the reported issue was found to be a defective water sensor assembly.Actions were taken to mitigate the reported issue: the water sensor assembly, pump and safety and valve solenoid were replaced.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LEVEL 1 HOTLINE 290 FLUID WARMING DEVICE
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
OAKDALE
3350 granada ave n
oakdale MN 55128
Manufacturer (Section G)
NULL
3350 granada ave n
oakdale MN 55128
Manufacturer Contact
jim vegel
6000 nathan lane n
minneapolis, MN 55442
7633833310
MDR Report Key13019379
MDR Text Key282346248
Report Number3012307300-2021-12701
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K001764
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/10/2023
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 NumberHL-290
Device Catalogue NumberHL-290
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/16/2021
Initial Date FDA Received12/16/2021
Supplement Dates Manufacturer Received04/28/2023
Supplement Dates FDA Received05/10/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-