MAUDE Adverse Event Report: AMBU A/S AMBU BLUE SENSOR VLC

Catalog Number VLC-00-S/25

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033)

Event Date 10/24/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The affected electrodes were not received for investigation, neither was lot number of the affected items provided.Pictures of patient's reactions was receive and did confirm skin reaction.Due to limited information, it is difficult to verify the reported failure and the root cause of the reported failure cannot be identified.It has not been possible to obtain further information regarding the incident.Biocompatibility testing of the electrodes is a requirement of the international organization for standardisation (iso) 10993 - biological evaluation of medical devices.The tests required for surface electrodes are: · sensitization study to evaluate the potential of the electrode to cause delayed dermal contact sensitization.Cytotoxicity study (in vitro) to determine the electrode's potential of causing cell death.· primary skin irritation to evaluate whether the topical application of the electrode can cause skin irritation.Device has passed biocompatibility testing.Despite ambu electrodes being developed and tested to assure that the materials are biocompatible, it is not possible to guarantee that no patients can eventually react to a certain substance contained in the gel or medical adhesive.

Event Description

Patient is wearing a holter monitor for 7 days.Patients has had mild brief reactions to small ecg electrodes in the past.Within 12 hours of wearing the electrodes patients developed a itchy red rash.Antihistamines was tried to no avail.The itching became intolerable and patient consulted her gp to start on prednisolone.Patient changed electrodes every day.On the 5th day of cardiac monitoring the reaction was painful, skin is bubbling, the reaction is severe and worsening.Patient was concerned she not to be able to finish the cardiac monitoring.

• Brand Name: AMBU BLUE SENSOR VLC
• Type of Device: BLUE SENSOR VLC
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU INC; 6230 old dobbin lane; suite 250; columbia MD 21045
• Manufacturer Contact: sanjay parikh ; baltorpbakken 13; ballerup, 2750 ; DA 2750 ; 7686464113
• MDR Report Key: 6104061
• MDR Text Key: 59976600
• Report Number: 9610691-2016-00006
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• PMA/PMN Number: D194483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: VLC-00-S/25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 75