MAUDE Adverse Event Report: AMBU A/S AMBU BLUE SENSOR N; ECG ELECTRODES

Model Number	N-00-S/25
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Localized Skin Lesion (4542)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are unable to verify the reported failure on (adhesive seems too strong) from the returned samples.The customer returned an opened pouch of 15 electrodes for investigation.Visual inspection did not reveal any abnormalities.Peel ease test was performed on 2 electrodes, where their removal from backing cap was observed and no abnormalities was observed.Next, electrode peel force test was performed on 13 electrodes, where peel force is measured after 24 hour application.The results showed that all samples met the specifications.Review of production record did not reveal any deviation.The adhering raw material was investigated.The coa of the adhesive was reviewed, the faceside adhesion test and liner releasing-gram test showed that the lot was delivered within the specification.Further information obtained from the customer revealed that the electrodes were used for brainstem evoked response audiometry / auditory brainstem response measurements, while the intended use for blue sensor n electrodes is for ecg monitoring/measurements of the heart to investigate cardiac rate, rhythm and/or abnormalities.It has been concluded that the possible cause of the reported failure is due to within lot adhesion performance variation of certain spot of the adhesive material.No corrective action is required based on risk assessment.Production, technical team and quality control have been made aware of this feedback via quality alert.We will continue monitoring the market for similar complaints.
Event or Problem Description
The failure was reported from phoniatrics and pediatric audiology department.The customer stated that the electrodes can only be painfully removed from the skin.The adhesive seems too strong, as three children have developed open skin lesions.

• Brand Name: AMBU BLUE SENSOR N
• Common Device Name: ECG ELECTRODES
• 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: 22384219
• Report Number: 9610691-2025-00017
• Device Sequence Number: 21023216
• Product Code: DRX
• UDI-Device Identifier: 05707480022106
• UDI-Public: 05707480022106
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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: 04/13/2026
• Device Model Number: N-00-S/25
• Device Catalogue Number: N-00-S/25
• Device Lot Number: 1000985202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2024
• 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