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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 Overheating of Device (1437)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Other text: b3: date of event is unknown, no information has been provided to date.Udi section of d4 is unknown.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 was overheating.There has been no report of patient involvement.
 
Manufacturer Narrative
Device available for evaluation; h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One device was received.Visual inspection noted a broken front cover, outdated printed circuit board (pcb) and power switch.Per functional testing the temperature of the device was running high confirming the complaint.The root cause was the device was out of calibration.The temperature pot on the pcb was adjusted and the temp was lowered.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.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
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 Key17551993
MDR Text Key321282193
Report Number3012307300-2023-08125
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 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-90
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/26/2023
Initial Date FDA Received08/15/2023
Supplement Dates Manufacturer Received09/28/2023
Supplement Dates FDA Received10/25/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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