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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 Overheating of Device (1437); Temperature Problem (3022)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Other, other text: 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 device was over temping even with the correct range.Patient involvement unknown.
 
Event Description
Additional information received via email."the unit was dropped off at their shop and there was no further information".
 
Manufacturer Narrative
One device was received very dirty.Per visual inspection line cord discolored, quick connect corroded, pole clamp discolored, printed circuit board (pcb) was missing a light emitting diode (led), microswitch and main block damaged, enclosure and front cover were scratched and had nicks in them.Per functional testing, the device was over temping confirming the complaint.The root cause was an inoperative water pump no longer recirculating water.It was unknown what caused it to become inoperative.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.
 
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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 Key17560325
MDR Text Key321318185
Report Number3012307300-2023-08172
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 10/25/2023
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-390
Device Catalogue NumberCON-HL-390
Was Device Available for Evaluation? No
Date Returned to Manufacturer08/09/2023
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/28/2023
Initial Date FDA Received08/16/2023
Supplement Dates Manufacturer Received09/28/2023
Supplement Dates FDA Received10/25/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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