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

Model Number HL-90

Device Problems Electrical /Electronic Property Problem (1198); Sparking (2595); Electrical Power Problem (2925)

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

Event Type  malfunction  

Manufacturer Narrative

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 required.

Event Description

It was reported that the fluid warmer sparked at the plug and blackened out the plug.Additional information received by smiths medical/icu on 3-jan-2023 via email: customer reported that they have replaced the mains plug and did the testing and it is ok.The machine has gone back in use.It seems like fluid must have shorted the pins on the plug and sparked.If need be, when the engineer comes to service the device in the summer he/she can replace the main lead which is hard wired from inside.Additional information received by smiths medical/icu on 5-jan-2023 via email: the device is not available for investigation; it was tested and found to be working fine.There has been no report of patient involvement, no observable clinical symptoms, or a change in symptoms identified in the patient.

Manufacturer Narrative

No product was returned, and no photographic evidence was provided to aid in this investigation.However, according to the description of the event, there was an electrical short at the power cord plug to the power outlet resulting in a spark and charred prongs.The exact cause could not be determined but this could only result from an electrical short caused by the customer plugging in a wet power cord plug, ruling out a fault in the power outlet itself.As per the customer, replacing the power plug eliminated the failure, therefore the most probable cause was fluid ingression onto the power cord plug.The customer had replaced the power cord plug and decided not to send the device in.As a result, a complaint investigation, product evaluation and problem confirmation cannot be performed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.No further action was taken.

• 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; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; great maze pond; minneapolis, MN 55442
• MDR Report Key: 16184424
• MDR Text Key: 308538200
• Report Number: 3012307300-2023-00516
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1