MAUDE Adverse Event Report: ST PAUL LEVEL 1 HOTLINE FLUID WARMER - 38 DEGREE UNIT; WARMER, THERMAL, INFUSION FLUID

Model Number	HL-90-38
Medical Device Problem Codes	Defective Component (2292); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was received for investigation.Investigators noted the device was received with broken led?s.Started with a visual inspection then filled tank with water, attached temp check, plugged in line cord, and turned on the power switch.Yes, the issue was duplicated.The led pins came off the printed circuit board (pcb) confirming the customer complaint.The investigators were able to determine customer damage caused by incorrect assembly of the front panel, caused the broken led?s.The pcb was replaced, and preventative maintenance was performed.A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.
Event or Problem Description
It was reported that the fluid warming device had physical damage.Led pins came off from board.No patient injury or adverse affects were reported.
Additional Manufacturer Narrative
Additional event information received indicating no patient involvement and date of event was received.(updated b5, b3).
Event or Problem Description
Additional info received via email 31-aug-2022.Event date was updated.Event occurred during preventive maintenance.No patient involvement.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER - 38 DEGREE UNIT
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15306374
• Report Number: 3012307300-2022-16441
• Device Sequence Number: 5287379
• Product Code: LGZ
• UDI-Device Identifier: 50695085002404
• UDI-Public: 50695085002404
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K911383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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
• Operator of Device: Health Professional
• Device Model Number: HL-90-38
• Device Catalogue Number: HL-90-38
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown