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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
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.A product sample was received for evaluation.Visual and functional testing were performed.Physical condition of the device showed poor, old style power switch was broken loose off the printed circuit board.Customer?s reported issue was duplicated.Power switch was broken off the printed circuit board causing the device to have no power.The root cause of the reported issue was determined to have been caused by normal wear and tear.This device uses an old-style printed circuit board where the power switch is soldered onto the board.The power switch was broken off.Actions taken to mitigate the reported issue: no action taken due to the age and condition.Device is deemed beyond economical repair and will be scrapped.Udi information is unknown.Initial reporter also sent report to fda is unknown.No information has been provided to date.Report source is unknown.
 
Event Description
It was reported that power switch issue event occurred.No patient injury 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
503 n 21st st 85-20
minneapolis, MN 55442
MDR Report Key15639932
MDR Text Key306686128
Report Number3012307300-2022-25419
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
Reporter Occupation Other
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 Manufacturer09/10/2019
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 Manufactured07/28/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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