MAUDE Adverse Event Report: AMBU A/S AMBU BLUESENSOR R; ELECTROCARDIOGRAPHIC ELECTRODE, SINGLE-USE

Catalog Number R-00-S/25

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Fall (1848)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

This mdr is resubmitted as it was discovered that this mdr has not been successfully loaded into fdas database.The initial reporting to fda of this case has been done to fda within the original deadline, however in the wrong file format to support correct upload.This submission represents a reload of data to ensure correct upload to the fda database.Customer did not return samples for investigation.Investigations have therefore been performed using retention samples from the same production month and review of quality records.Visual inspection and electrical test were performed on the retention sample and no abnormalities were observed on the electrodes.The retention samples appear to be within specifications and all the tested electrodes pass the electrical test.Following the compliant information, no lot nr.Was received.Quality records were therefore investigated for the 3 lot's which were manufactured in the same month as the one included in the incident (data based on expiry date of implicated device).No defects/incident was observed in the manufacturing record that could be linked to this failure.The electrical performance of the retention samples shows no abnormality.The possible causes for no signal may be do to poor adhesion.Poor adhesion can be caused by the sweat of patient or there has been a gel leakage on the electrodes caused by improper handling (by production staffs and/or customer which accidentally press the pouch/electrodes) or the connection of electrodes were loosen during the movement of patient.These causes may lead to electrodes does not adhere well and subsequently cause no signal.Based on the clarification from the complaint creator the electrodes were initially working and later when no signal was recored the electrodes still appeared to be sitting on the patient.Following this is it suspected that the electrodes loosened while taking the reading but still on the patient.Initially the electrodes were functioning, and after the patient was moved, the electrodes failed to record the signal.As the device was discarded the device can not be investigated.Following the available information and investigations it can not be concluded what caused the loss of ecg signal.In the event of electrode failure, the monitoring device is supposed to trigger an alarm when signal is lost as the electrode are not able to trigger any alarm itself.In conclusion, the electrode could not be main cause of the event as the electrode functions together with monitoring system.The monitoring system should be able to detect the loss of signal by triggering alarm to mitigate the risk.The product risk evaluation includes and evaluates the hazardous situation of ecg signal lost on the monitor/ electrodes not functioning.The electrodes are only intended to transmit the electrical signal at the body surface to a recording and monitoring device.The failure of electrodes will only lead to the unable of monitoring.Telemetry device are designed to send an alarm when electrodes are disconnected, and should therefore detect the loss of signal by triggering alarm, mitigating any risks.Poor adhesion of electrodes will cause user inconvenience as electrodes may need to be replaced.The risk has been assessed with a severity of 1 (harm will result in inconvenience or temporary discomfort) and a probability of p=1 (occurs in 1/1 000 000).The risk is evaluated as acceptable and this incident does not change this conclusion.

Event Description

Patient collapsed in patient room at 17:20.No telemetric recorded between 15:50 - 17:20.Patient in monitoring but electrode/electrodes were loose.It looked as electrodes were attached but nothing was recorded on the monitor.Electrodes detached at 18:00 and changed, after which the monitoring worked without complications.Following the initial reporter this episode could had been dangerous for the patient as the cause to the collapse was not recorded as it happened.Diagnosis delayed and patient care was also prolonged.

• Brand Name: AMBU BLUESENSOR R
• Type of Device: ELECTROCARDIOGRAPHIC ELECTRODE, SINGLE-USE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer Contact: mingye zhang ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 12116474
• MDR Text Key: 262416456
• Report Number: 9610961-2020-00007
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: R-00-S/25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization