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

Model Number HL-90

Device Problem Overheating of Device (1437)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown, no information has been provided to date.No 510k as product not sold in us.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 was overheating "above 43 degrees".Patient involvement unknown.

Manufacturer Narrative

Other, other text: additional information: b3, b5, and h6 - health effects codes: updated.

Event Description

Additional information was received confirming the event occurred during the preparation phase.No patient harm, injury, or adverse effects.

Manufacturer Narrative

One device was received.Upon removing the front enclosure light emitting diode (led) fell out and was otherwise in good physical condition.Powered the device on and let run for an hour and it worked properly.Temperature was stable on 41.9 degrees celsius and after pressing the "over temperature alarm test" button the device stopped, but alarm did not sound that could have been caused by the broken light emitting diode (led).Unable to replicate or confirm the complaint.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 in the previous 12 months and there was no indication that the complaint was related to a previous service of the device.The printed wiring assembly (pwa) was replaced.No further action was taken as the complaint could not be confirmed.

• 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: 16790434
• MDR Text Key: 314009845
• Report Number: 3012307300-2023-04381
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• 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-UK-230
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/12/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1