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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OAKDALE CONTINENTAL EUROPEAN 230 VOLT LEVEL 1 HOTLINE; WARMER, THERMAL, INFUSION FLUID

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OAKDALE CONTINENTAL EUROPEAN 230 VOLT LEVEL 1 HOTLINE; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-90
Device Problems Device Alarm System (1012); Temperature Problem (3022)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Other text: b3: date of event and d4: udi number 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 fluid warmer would not work.The screen indicates a temperature of 74 degrees and the temperature "fault" indicator was lit.Patient involvement unknown.
 
Manufacturer Narrative
Event methods, evaluation, and conclusion codes: updated.One warmer device was received for investigation.During visual inspection the device was observed to have the front enclosure was removed and the light emitting diode fell out.The reported issue was confirmed during functional testing when the device was powered on and the screen would only display a temperature of 71 degrees, and wouldn't adjust.The investigation traced the issue to the printed wire assembly and heater, which were determined to be faulty.However, the investigation could not identify a root cause for the components' condition.The printed wire assembly and heater were replaced.As no manufacturing root cause could be identified, no review of manufacturing device history records was conducted.A review of device confirmed this device has not been in for service in the previous 12 months.
 
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Brand Name
CONTINENTAL EUROPEAN 230 VOLT LEVEL 1 HOTLINE
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 Key16899506
MDR Text Key314897663
Report Number3012307300-2023-05436
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
K911383
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/07/2023
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 Other
Device Model NumberHL-90
Device Catalogue NumberHL-90-INT-230
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/03/2023
Initial Date FDA Received05/09/2023
Supplement Dates Manufacturer Received05/25/2023
Supplement Dates FDA Received06/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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