MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE FLUID WARMER, 90; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problem Failure to Calibrate (2440)

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

Event Type  malfunction  

Event Description

It was reported the device could not be calibrated.No patient involved.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A manufacturing device history record (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.A sample was received to perform an investigation.A visual inspection of the returned warmer found wear and tear damaged enclosure, tank cover, front cover, and line cord.Event history log review was not applicable.Functional testing was performed by filling the reservoir with water, attaching the temperature check to hotline, plugging in the line cord, and turning on the power switch to perform safety/electrical test.Tried to adjust the printed circuit board (pcb) but it was not accepting adjustments.The reported problem was due to a faulty pcb.The root cause was unable to be determined.Replaced the pcb.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 90
• 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; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 13003300
• MDR Text Key: 282382311
• Report Number: 3012307300-2021-12711
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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 Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1