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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

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OAKDALE LEVEL 1 HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-90
Device Problem No Display/Image (1183)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
It was reported that the warmer display is not working.There has been no report of patient involvement, no observable clinical symptoms, or a change in symptoms identified in the patient.
 
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.
 
Manufacturer Narrative
Other, other text: h3.Device evaluated by manufacturer and h6.Health impact and evaluation codes: updated one device was returned for investigation with a cracked enclosure and a damaged line cord.Filled tank with water, attached temp check, plugged in line cord, and turned on the power switch.Performed functional tests.The liquid crystal display (lcd) was damaged and not working confirming the customer complaint.Root cause of the issue was found to be due to impact damage.A device history record (dhr) review was not done as the device is more than a year beyond the manufacturing date.A service history review showed that the device had not been in for service in the previous year.No action was taken due to the device being beyond economical repair.
 
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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
3350 granada ave n
oakdale MN 55128
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key16542011
MDR Text Key311292021
Report Number3012307300-2023-02440
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K911383
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 05/03/2023
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 Manufacturer03/08/2023
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/22/2023
Initial Date FDA Received03/14/2023
Supplement Dates Manufacturer Received05/01/2023
Supplement Dates FDA Received05/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/14/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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