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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
Model Number HL-90
Device Problem No Display/Image (1183)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Date of event and d4: udi section are unknown, no information has been provided to date.Device evaluation: one device was received for investigation.Visual inspection found the device was received with broken a reflux plug, discolored pole clamp and some chips out of the paint on the bottom of the unit.Functional testing confirmed the complaint; the display would come on for a second and then go blank.Root cause was listed as physical impact causing a bad printed circuit board (pcb) and missing stand offs behind the board.A manufacturing device history report (dhr) review was not performed because the device is beyond a year from its manufacture date and there was no indication of a manufacturing defect during the investigation.Service history review identified this device has not been in for service previously.Replaced the printed circuit board (pcb), pole clamp, and the reflux plug.Performed preventative maintenance and calibration.Device passed functional testing after the completed repairs.
 
Event Description
It was reported that the display was no longer working.Patient involvement is unknown.
 
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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)
NULL
Manufacturer Contact
jim vegel
MDR Report Key17130745
MDR Text Key317248244
Report Number3012307300-2023-06247
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 Other Health Care Professional
Type of Report Initial
Report Date 06/14/2023
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 Model NumberHL-90
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/30/2023
Initial Date FDA Received06/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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