• 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 FLUID WARMER; 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 FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-90
Device Problems Defective Alarm (1014); No Audible Alarm (1019); Alarm Not Visible (1022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that during preventative maintenance, when the tubes come off the alarms do not go off.No adverse effects reported.
 
Manufacturer Narrative
Other text: b3: date of event and d4: udi section are unknown, no information has been provided to date.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.
 
Manufacturer Narrative
Other, other text: g1,2 email is: regulatory.Responses@icumed.Com.One device received as a con-hl-90 but came in with an hl-390 main block.Per visual inspection, printed circuit board (pcb) was missing light emitting diodes (led)s, front cover was broken on the bottom that holds the screw, global display label had a dent on the right side, water tank cover had a crack, quick connect was corroded, outdated pcb and power switch, pole clamp has non-oem handle.Per functional testing, unable to duplicate alarms as the pcb was damaged.The most probable cause was damage to the pcb.Broken off check disposable alarm indicator led from pcb board.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.No action taken due to the condition of the device.It was deemed beyond economical repair and was scrapped.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LEVEL 1 HOTLINE FLUID WARMER
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
OAKDALE
3350 granada ave n
oakdale MN 55128
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key18105708
MDR Text Key327781749
Report Number3012307300-2023-10402
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier50695085820909
UDI-Public50695085820909
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001764
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/08/2023
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-90
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? No
Date Returned to Manufacturer11/03/2023
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/23/2023
Initial Date FDA Received11/09/2023
Supplement Dates Manufacturer Received11/17/2023
Supplement Dates FDA Received12/08/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2000
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-