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

Model Number HL-90

Device Problem Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Date of event and udi number is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.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 device would not power on.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Other, other text: device evaluation: one warmer device was received for investigation.During visual inspection the device was observed to have a cracked enclosure and damaged power switch.The reported issue was confirmed during functional testing when the device would not power on.The issue was traced to the damaged power switch.However, no root cause could be attributed for this condition.As no manufacturing root cause could be identified, no review of manufacturing device history records was conducted.A review of device confirmed this device has not been in for service previously.Due to the age of the device, it has been deemed beyond economical repair and will be decommissioned.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER
• 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: 16597639
• MDR Text Key: 311833797
• Report Number: 3012307300-2023-02945
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

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?: No
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 05/02/2023
• Supplement Dates FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1