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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 Power Problem (3010)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2021
Event Type  malfunction  
Event Description
Information received a smiths medical fluid warming|level 1 hotline low flow systems - hl-90 malfunctioned.Issue discovered (b)(6) 2021.Staff reported no power and it was confirmed to be an intermittent issue due to the solder joint on the board.
 
Manufacturer Narrative
Device evaluation - the device was returned for evaluation.The device was given functional testing.The device could be successfully powered on with no issues.Investigation determined excessive pump noise occurred but the reported issue was not confirmed.
 
Manufacturer Narrative
This mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.A product sample was received for evaluation.Visual and functional testing were performed.Device was received in with in appearance a new enclosure kit.The line cord is worn and the device contains an old style board.The technician plugged in device and powered on.The report issue was not confirmed.Device powered up with the operating indicator lit.The root cause of the reported issue was unable to be determined, problem may be intermittent and was not able to duplicate at the time of evaluation.There were other problems found with a loud pump.No action taken due to the age and condition.Unit was scrapped.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
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
7633833310
MDR Report Key12350609
MDR Text Key267562591
Report Number3012307300-2021-08694
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 Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 02/24/2023
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 Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/22/2021
Initial Date FDA Received08/20/2021
Supplement Dates Manufacturer Received11/23/2021
02/02/2023
Supplement Dates FDA Received12/23/2021
02/23/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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