• 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 Fluid/Blood Leak (1250); Insufficient Heating (1287); Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Date of event and udi number is 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.
 
Event Description
It was reported the device was leaking and would not heat.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
 
Manufacturer Narrative
Other, other text: h3 and h6 conclusion codes: updated.Device evaluation: one device was returned for investigation.Upon visual inspection a cracked enclosure, bent prongs on line cord, missing plate clip, outdated printed circuit board (pcb) and outdated power switch were noted.The complaint was confirmed when the device leaked near the drain fitting and would not heat during functional testing.A crack in the enclosure caused the leak and a faulty heater will not heat the water in the reservoir.A manufacturing device history report (dhr) review was not performed because the device is beyond a year from its manufacture date of 2004 and there was no indication of a manufacturing defect during the investigation.Service history review identified this device has not been in for service previously.It was determined the water leak from cracked tank near the drain tube fitting was caused from wear of usage.The heater failure was caused from wear of age.The device was manufactured in 2004 and had not been in for service prior to being returned for this complaint.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be 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 Key16597576
MDR Text Key312039612
Report Number3012307300-2023-02944
Device Sequence Number1
Product Code LGZ
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 05/05/2023
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 Manufacturer03/21/2023
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/10/2023
Initial Date FDA Received03/23/2023
Supplement Dates Manufacturer Received05/02/2023
Supplement Dates FDA Received05/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/09/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-