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

Model Number HL-90-38

Device Problems Defective Component (2292); Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2022

Event Type  malfunction  

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 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.

Manufacturer Narrative

Additional event information received indicating no patient involvement and date of event was received.(updated b5, b3).

Event 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
• Type of Device: 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
• MDR Text Key: 305257395
• Report Number: 3012307300-2022-16441
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085002404
• UDI-Public: 50695085002404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 08/31/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1