MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE CONTINENTAL EUROPEAN 230 VOLT; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problems Device Alarm System (1012); No Audible Alarm (1019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of event and 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 required.

Event Description

It was reported that during "commissioning the alarm of device " no tubing was not present " did not work." no patient involved for this issue.

Manufacturer Narrative

Other, other text: h3.Device evaluated by manufacturer and h6.Health impact, event problem and evaluation codes: updated one device was returned for evaluation in good physical condition.The device was functionally tested where it was found that no audible alarm was heard confirming the customer complaint.The issue was found to be due to the microswitch on the printed circuit board having too little tolerance causing the alarm to not sound.Root cause of the issue was not able to be determined.The microswitch was replaced and when the device was tested, it was found to be functioning as intended.A device history record (dhr) review found no printed circuit board (pcb) or other issues during manufacturing.

• Brand Name: LEVEL 1 HOTLINE CONTINENTAL EUROPEAN 230 VOLT
• 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: 16569448
• MDR Text Key: 311568121
• Report Number: 3012307300-2023-02691
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2023
• 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-INT-230
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1