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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
Catalog Number CON-HL-390
Device Problem Failure to Calibrate (2440)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2021
Event Type  malfunction  
Event Description
It was reported that the device would not pass preventative maintenance procedure.No patient was involved.
 
Manufacturer Narrative
One device was returned for investigation.The returned sample was visually inspected, and the device was noted to have a cracked enclosure and tank cover, the lcd was smashed from the front cover, and parts of the printed circuit board were broken off.The customer?s complaint was confirmed; it was determined that the device could not be calibrated because of a faulty circuit board.It was determined that the cause of the issues was from customer error.Customer tried to adjust the circuit board.No action was taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.The manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.
 
Manufacturer Narrative
One device was returned for investigation.The returned sample was visually inspected, and the device was noted to have a cracked enclosure and tank cover, the lcd was smashed from the front cover, and parts of the printed circuit board were broken off.The customer?s complaint was confirmed; it was determined that the device could not be calibrated because of a faulty circuit board.It was determined that the cause of the issues was from customer error.Customer tried to adjust the circuit board.No action was taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.The manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.
 
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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)
OAKDALE
3350 granada ave n
oakdale MN 55128
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key13599406
MDR Text Key286655880
Report Number3012307300-2021-13363
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 03/22/2022
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-390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/24/2021
Initial Date FDA Received02/25/2022
Supplement Dates Manufacturer Received03/25/2022
Supplement Dates FDA Received03/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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