MAUDE Adverse Event Report: AMBU A/S AMBU NEUROLINE CUP ELECTRODES; AMBU EEG LEADS

Catalog Number UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Lead(s), Burn(s) From (3161)

Event Date 01/16/2019

Event Type  Injury  

Manufacturer Narrative

There were no catalog number, lot number or complaint sample available for further investigations.The complaint was received through a fda maude report, which only identify that an ambu eeg electrodes were involved in the described event, without any specifications on the product.Neither did the maude report include name or contact information of the initial reporter, so no follow-up questions could be asked.We were therefore unable to investigate the failure due to limited and incomplete information provided.However, ambu cup eeg electrodes are intended only for recording biopotential signals, and do not act as a stimulator, meaning that the electrodes are passive and can not generate any current and thereby not cause electrical burns when used according to ifu.

Event Description

Patient waw wearing the cup-electrodes over a proximal period of 24h, and experienced red burns, when removing the electrodes.

• Brand Name: AMBU NEUROLINE CUP ELECTRODES
• Type of Device: AMBU EEG LEADS
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, DK-27 50; DA DK-2750
• Manufacturer (Section G): AMBU INC; 6230 old dobbin lane; suite 250; columbia MD 21045
• Manufacturer Contact: sanjay parikh ; 6230 old dobbin lane; suite 250; columbia, MD 21045 ; 4107686464
• MDR Report Key: 8487914
• MDR Text Key: 141079739
• Report Number: 9610691-2019-00005
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/08/2019,04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2019
• Date Manufacturer Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other