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

Model Number HL-90

Device Problems Failure to Power Up (1476); Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

B3: date of event 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 turn 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

Device available for evaluation; h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One device was received with a cracked enclosure and tank cover, damaged line cord cover, screw stuck in pole clamp, worn block assembly, and damaged connection between the printed circuit board (pcb) and power switch.When plugging the line cord into a power source and turning on the power switch the device had no power confirming the complaint.The root cause was the connection between the pcb and power switch was damaged.A device history record (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.Replaced the enclosure, tank cover, line cord, pole clamp, and block assembly.Also replaced the pcb and power switch.Performed preventative maintenance (pm).Device passed all functional and delivery tests.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND 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: 16738037
• MDR Text Key: 313327349
• Report Number: 3012307300-2023-04108
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: 50695085820909
• 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: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• 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: HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1