MAUDE Adverse Event Report: AMBU SDN.BHD. AMBU EEG LEADS; ELECTRODE, CUTANEOUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 01/16/2019

Event Type  Injury  

Event Description

Following a hospitalization for a stroke, (b)(6) was admitted to university hospital in (b)(6)on jan 14th to the er.There she spent all day and night in the er and then on monday was placed on an eeg with the ambu leads.She was then transferred to an icu bed on tuesday late morning where she still had the eeg on.On wednesday when the decision was made by the family, present there to cease therapy and remove the leads and transfer her to a hospice bed, the tech and nurse present removed the leads and severe burns were noted to the shock of the nurse and tech.Pictures enclosed.These severe burns, according to the tech and nurse should not have happened and if it were not for the decision to remove the leads, the burns could have been even more severe and since the forehead has such little skin, it would have reached the bone.This adverse effect is not acceptable and should not have to happen to anyone else especially since the nurse said that the hospital switched to these recently and that they are also used in pediatric cases too.Since the patient was not responsive, there is no way to see if additional pain was inflicted due to the burning from these leads.A report was to be filed by the nurse to the hospital but that has not been confirmed at this time.I am also sending this report to the administration.

• Brand Name: AMBU EEG LEADS
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): AMBU SDN.BHD.; 6230 old dobbin ln; ste 250; columbia MD 21045
• MDR Report Key: 8358877
• MDR Text Key: 137242681
• Report Number: MW5084163
• Device Sequence Number: 0
• Product Code: GXY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 54