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

Model Number HL-90

Device Problem Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

B3: date of event and d4: udi section are 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 warmer had a system failure.Patient involvement is unknown.

Manufacturer Narrative

H6 evaluation codes: updated device evaluation: one device was received for investigation.Visual inspection noted a cracked enclosure, outdated (printed circuit board (pcb) and outdated power switch.Functional testing confirmed the complaint.The heater caused the device to fail our safety/electrical test confirming the customer complaint.The root cause of the faulty heater could not determined.A manufacturing device history report (dhr) review was not performed because the device is beyond a year from its manufacture date and there was no indication of a manufacturing defect during the investigation.Service history review identified this device has not been in for service previously.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.

• 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: 16865237
• MDR Text Key: 314545645
• Report Number: 3012307300-2023-05023
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1