MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID

Model Number HL-390

Device Problem Device Alarm System (1012)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Other, other text: udi section of d4 is unknown, no product information has been provided to date.B3: date of event is unknown, no information has been provided to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the warmer had no available alarm.No report of patient involvement.

Event Description

Additional information received via email.The event date was unknown.No adverse patient effects were reported by the customer.

Manufacturer Narrative

Other, other text: g1, h3, h6 - updated one device was received for investigation.During visually inspection and functionally tested it was found that the reported problem was duplicated.The complaint is confirmed.The primary root cause was that the pcb was damaged.The pcb will be replaced.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.D3, g1, and g2 email is: (b)(6).

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 390
• 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 Key: 16891335
• MDR Text Key: 314849455
• Report Number: 3012307300-2023-05347
• Device Sequence Number: 1
• Product Code: LGZ
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2024

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-390
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 08/23/2023; 01/31/2024
• Supplement Dates FDA Received: 08/28/2023; 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1