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

Model Number HL-90

Device Problems Device Alarm System (1012); Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Other text: b3: date of event and d4: 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 fluid warmer would not work.The screen indicates a temperature of 74 degrees and the temperature "fault" indicator was lit.Patient involvement unknown.

Manufacturer Narrative

Event methods, evaluation, and conclusion codes: updated.One warmer device was received for investigation.During visual inspection the device was observed to have the front enclosure was removed and the light emitting diode fell out.The reported issue was confirmed during functional testing when the device was powered on and the screen would only display a temperature of 71 degrees, and wouldn't adjust.The investigation traced the issue to the printed wire assembly and heater, which were determined to be faulty.However, the investigation could not identify a root cause for the components' condition.The printed wire assembly and heater were replaced.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 in the previous 12 months.

• Brand Name: CONTINENTAL EUROPEAN 230 VOLT LEVEL 1 HOTLINE
• 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: 16899506
• MDR Text Key: 314897663
• Report Number: 3012307300-2023-05436
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2023

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: Other
• Device Model Number: HL-90
• Device Catalogue Number: HL-90-INT-230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1