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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 Failure to Calibrate (2440)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2021
Event Type  malfunction  
Event Description
It was reported the device had "temperature issues".Issue was found during preventive maintenance; no patient involved.
 
Manufacturer Narrative
Device evaluation- the device was returned for evaluation.The device was given functional testing and this showed the over temperature alarm was out of calibration.However the reported issue was not confirmed; the over temperature alarm was successfully calibrated.
 
Event Description
Additional information received via email 02-nov-2021: date of event updated, the reported issue did not occur while in use with a patient, and there was no adverse event.
 
Manufacturer Narrative
Other, other text: additional:d4 udi is unknown.No product information has been provided to date.B5,, d5, h6.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No manufacturing or service issues were identified as causes of the customer's reported problem during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Device was received in with a cracked enclosure underneath the drain fitting, contained old style printed circuit board (pcb), drain fitting, and line cord.The enclosure has normal wear and tear.The technician attempted to calibrate with temperature check e5768 due (b)(6) 2022.The reported issue was not confirmed.The overtempt pot r106 was raised extremely high, but managed to perform calibration.The root cause of the reported issue was found to be the technician or users inability to perform calibration.No action taken due to the age and condition.Unit will be scrapped.
 
Event Description
Additional information received via email 02-nov-2021: date of event updated, the reported issue did not occur while in use with a patient, and there was no adverse event.
 
Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No manufacturing or service issues were identified as causes of the customer's reported problem during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Device was received in with a cracked enclosure underneath the drain fitting, contained old style printed circuit board (pcb), drain fitting, and line cord.The enclosure has normal wear and tear.The technician attempted to calibrate with temperature check e5768 due (b)(6) 2022.The reported issue was not confirmed.The overtempt pot r106 was raised extremely high, but managed to perform calibration.The root cause of the reported issue was found to be the technician or users inability to perform calibration.No action taken due to the age and condition.Unit will be scrapped.
 
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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
777 bannock st
minneapolis, MN 55442
7633833310
MDR Report Key12763089
MDR Text Key280473634
Report Number3012307300-2021-10802
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 Health Professional,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 03/06/2023
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 Manufacturer11/23/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/11/2021
Initial Date FDA Received11/07/2021
Supplement Dates Manufacturer Received11/23/2021
02/03/2023
02/03/2023
Supplement Dates FDA Received12/22/2021
03/03/2023
03/06/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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