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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

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OAKDALE LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Catalog Number HL-90
Device Problems Device Alarm System (1012); Defective Alarm (1014)
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.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 water level alarm would not shut off.Patient involvement unknown.
 
Manufacturer Narrative
Other, other text: g1,2 email is: regulatory.Responses@icumed.Com.One device was received.Per visual inspection, there were a lot of scuff marks, water tank cover was cracked, front cover had scratches and nicks in the paint, quick connect corroded, pole clamp discolored.Per functional testing, the water level alarm went off immediately.The complaint was confirmed.The root cause was a faulty float switch.It was unknown what caused it to become faulty.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.Replaced float switch, water tank cover, front cover, quick connect, pole clamp.The device passed all functional and delivery tests.
 
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Brand Name
LEVEL 1 HOTLINE BLOOD AND 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 Key18059100
MDR Text Key327209146
Report Number3012307300-2023-10193
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier50695085820909
UDI-Public50695085820909
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 12/07/2023
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 NumberHL-90
Was Device Available for Evaluation? No
Date Returned to Manufacturer10/23/2023
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/13/2023
Initial Date FDA Received11/02/2023
Supplement Dates Manufacturer Received11/14/2023
Supplement Dates FDA Received12/07/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/02/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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