MAUDE Adverse Event Report: AMBU A/S BLUE SENSOR PECG ELECTRODES; AMBU BLUE SENSOR P

Catalog Number	P-00-S/50
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Anaphylactoid / Anaphylaxis (2218)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are unable to verify the reported failure on skin reaction due to no affected sample has been returned or photo of skin reaction from customer.After a thorough evaluation of all available information concerning the composition of the materials and parts as described and toxicologically assessed and safety evaluation of biological data, including review of declarations and statements provided by the suppliers for all materials e.G.Material characterization questionnaire and declaration forms (mcqd), and review of the extractable and leachable substances, the natural rubber latex, dry natural rubber, or rubber that contains natural rubber substances are not present in the device.We could suspect that certain part of the body of particular patient could be sensitive to components in the electrodes whether adhesive, sponge or the wet gel which could lead to skin reaction.No corrective action is required based on risk assessment.Production, technical team and qc were made aware on this incident via quality alert.We will continue monitoring the market for similar incidents.
Event or Problem Description
Patient experienced a severe allergic reaction within 5 minutes of the electrodes being applied to the skin.They started to feel itchy and urticaria developed.The electrodes were removed immediately and the skin wiped thoroughly.However the patient then began to develop further symptoms of anaphylaxis.Electrodes were removed and patient's skin wiped thoroughly.Appropriate treatment administered for anaphylaxis.Ambu was contacted to inform yourselves of the incident by both the clinical staff and patient and also to ascertain if there was any possibility that the electrodes may contain latex.A datasheet and skin reaction letter was provided and advice given to submit a complaint.

• Brand Name: BLUE SENSOR PECG ELECTRODES
• Common Device Name: AMBU BLUE SENSOR P
• 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, mys 1900, ; MY 1900,
• Manufacturer Contact: catharina engelhardt ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 23614461
• Report Number: 9610691-2025-00029
• Device Sequence Number: 9997487
• Product Code: DRX
• UDI-Device Identifier: 05707480022168
• UDI-Public: 05707480022168
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2026
• Device Catalogue Number: P-00-S/50
• Device Lot Number: 1001133752
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• 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: Required Intervention
• Patient Sex: Unknown