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 Problem Insufficient Information (4580)

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.

Manufacturer Narrative

Device evaluation: one device was returned for investigation.Visual inspection noted a broken power switch with a damaged printed circuit board (pcb) and a cracked tank cover.Functional testing confirmed the customer complaint when the alarms were triggered but there was no sound.Root cause was attributed to a faulty pcb.Product was beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a device history report (dhr) review was not required.Service history review identified this device has not been in for service previously.No action taken due to the condition of the device.It is deemed beyond economical repair and will be scrapped.

• 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: 16890109
• MDR Text Key: 314814090
• Report Number: 3012307300-2023-05326
• 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
• Report Date: 07/28/2023

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-390
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/20/2023
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1