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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
Catalog Number CON-HL-90
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Udi information is unknown.This mdr was generated under protocol (b)(4)., as a result of warning letter cms# (b)(4).A device history review is not applicable or relevant due to the device manufactured date of 2012.The investigation did not implicate a service process issue.A product sample was received for evaluation.Functional and visual testing were performed.The device was received in fair condition.The evaluation was performed, and the reported issue was confirmed.There is no sound when alarms are activated.After a new printer circuit board (pcb) was installed and the device under test alarmed as intended.The root cause of the reported issue was undetermined.No further actions were required.
 
Event Description
It was reported that the speaker was not working.No patient injury was reported.
 
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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)
OAKDALE
3350 granada ave n
oakdale MN 55128
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key15639709
MDR Text Key306621013
Report Number3012307300-2022-25411
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 Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/20/2022
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 Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/07/2022
Initial Date FDA Received10/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/26/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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