MAUDE Adverse Event Report: AMBU A/S BLUE SENSOR VL; ECG ELECTRODE

Model Number	VL-00-S/25
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are unable to verify the reported failure (electrode/gel too sticky) as no sample was returned for investigation.Review of production record shows that lot 1001139644 has passed production self-inspection and qc inspection with no deviation found.Double-coated adhesive raw material was tested with the faceside adhesion test and liner releasing-gram test, which showed that the corresponding lot was delivered within specifications as per certificate of analysis.Test report on electrode peel force has been reviewed showing that the verification test was within specification, ruling out product design issues.The ifu 0226 cardiology surface electrodes instructs on electrode removal: ' gently lift the tab or the edge of the electrode, maintaining a low profile, and slowly pull off the electrode from the skin, holding and supporting down the newly exposed skin as the electrode is removed.Keep the electrode close to the skin surface when pulling back over itself.Avoid removing the electrode at 45-degree angle, to reduce the risk of mechanical trauma' the possible cause for the reported failure could be due to within lot adhesion performance variation of certain spot of the adhesive material.Production, technical team and quality control have been made aware of this feedback via quality alert.We will continue monitoring the market for similar incidents.
Event or Problem Description
Two patients were involved and experienced ripping of skin upon removal of the blue sensor vl electrodes.The patients were provided with additional care.

• Brand Name: BLUE SENSOR VL
• Common Device Name: ECG ELECTRODE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU SDN. BHD.; lot 69-b, lintang; bayan lepas 6, phase iv; penang, 11900 ; MY 11900
• Manufacturer Contact: lenka vaculciakova ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 22663569
• Report Number: 9610691-2025-00020
• Device Sequence Number: 7449380
• Product Code: DRX
• UDI-Device Identifier: 05707480022250
• UDI-Public: 05707480022250
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: VL-00-S/25
• Device Catalogue Number: VL-00-S/25
• Device Lot Number: 1001139644
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown