We’re experiencing issues with our datasets and search. We apologise for any inconvenience while we work to fix this.
Mindray Medical Australia Pty Ltd is conducting a product correction for the BeneHeart D1 Automated External Defibrillator (AED).
The operator’s manual is being updated to help users better understand the procedure for switching patient types.
Product details
| ARTG Number | Product | Model(s) |
|---|---|---|
| 166368 | BeneHeart D1 Automated External Defibrillator | BeneHeart D1 |
What is the problem?
To help users better understand the procedure for switching patient types on the Mindray BeneHeart D1 Automated External Defibrillator (AED), Mindray has updated the Operator’s Manual with refined guidance. The details of the updates are as follows:
- Section 5.4 "AED Procedure" of the Operator’s Manual is supplemented with the following content "Check the patient type on the defibrillator. If the patient type is inconsistent with the current patient, select the image below to set the patient type correctly."
- Section 5.4 "The NOTE" of the Operator’s Manual is supplemented with the following content: "After MR60 or MR61 electrode pads are connected to the defibrillator and the patient, the defibrillator switches to Adult mode. When the indicated patient type is found inconsistent with the patient, you need to manually change the patient type.”
This Operator’s Manual revision only adds supplementary information. No changes have been made to the product itself or its operational procedures.
What is the risk?
When the device is set to paediatric mode and used for adult patients, there is a risk of ineffective defibrillation. Since adults generally require much more energy than children, insufficient energy may prevent the generation of a sufficient current to fully depolarise the heart muscle.
To reduce this risk, the device defaults to adult mode, which is accompanied by voice prompts and interface images indicating the current patient type’s status.
No reports of injuries due to this problem have been received.
What should I do?
- Review the new electronic Operator’s Manual supplied by Mindray Medical Australia - BeneHeart D1 Automated External Defibrillator Operator’s Manual.
- As outlined in the manual, when the indicated patient type is different to the patient, you need to manually change the patient type.
- The Mindray BeneHeart D1 AED can be used as per routine practice.
Further information
Please contact Mindray Medical Australia on 1800 793 011 or email service.au@message.mindray.com for further information.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.