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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID

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OAKDALE LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-390
Device Problems Device Alarm System (1012); Fracture (1260); Temperature Problem (3022)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
B3: date of event and d4: 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, that the unit had a cracked bottom at the plastic casing.And a high temperature alarm.Patient involvement unknown.
 
Manufacturer Narrative
Device available for evaluation, h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: (b)(6).One device was received.Per visual inspection, the water tank cover was cracked, pump was not working, front cover chipped.Per functional testing, the device was leaking from the bottom left side of the water tank cover and the device was out of calibration causing the high temperature alarm.The root cause was a cracked water tank cover and pump was not working.It was unknown what caused the condition.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.Replaced the water tank cover and the pump, front cover.Replaced o-rings, reservoir gasket for preventative maintenance (pm) and calibrated.The device passed all functional and delivery tests.
 
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Brand Name
LEVEL 1 HOTLINE FLUID WARMER, 390
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 Key16890464
MDR Text Key314824685
Report Number3012307300-2023-05337
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier10695085002796
UDI-Public10695085002796
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/18/2024
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-390
Device Catalogue NumberCON-HL-390
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/01/2023
Initial Date FDA Received05/08/2023
Supplement Dates Manufacturer Received12/21/2023
Supplement Dates FDA Received01/18/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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