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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  
Event Description
It was reported that the water level alarm would not shut off.Patient involvement unknown.
 
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.
 
Manufacturer Narrative
Other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: (b)(4).One device was received.Per visual inspection, discolored pole clamp, quick connect corroded, scratches in the paint on the enclosure, global display label had dents in it.Per functional testing, the water level alarm (float switch) was alarming.The complaint was confirmed.The root cause was a malfunctioning float switch from spliced connector wires by the user.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, printed circuit board (pcb) (due to service error), quick connect, global display label.Performed preventative maintenance (pm), changed o-rings, reservoir gasket and calibrated.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 Key18059255
MDR Text Key327210329
Report Number3012307300-2023-10196
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 Manufacturer10/19/2023
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 Manufactured05/21/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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