All ZeniPower mercury-free hearing aid batteries – low risk of batteries exploding during use or if depleted
- Medicines and Healthcare products Regulatory Agency
- 10 March 2016
- 10 March 2016
- Alert type:
- Medical device alert
- Medical speciality:
- General practice and Pharmacy
Manufactured by Zhuhai Zhi Li Battery Co Ltd – stop using batteries with certain best before dates (MDA/2016/003)
- Identify affected batteries (see device section).
- Do not use batteries with a best before date of ‘08-2018’ and ‘09-2018’. This date is on the outer blister packaging.
- If in doubt do not use.
- Ensure all cochlear implant and hearing aid patients receive a copy of this medical device alert, that they understand the problem and do not use the batteries.
- Contact your supplier to arrange for replacement batteries and ensure there is a system in place to supply users with these batteries.
Audiology departments and staff responsible for these devices.
Deadlines for actions
Actions underway: 24 March 2016
Actions complete: 22 April 2016
Only batteries with best before dates of ’08-2018’ and ‘09-2018’ are affected.
If you purchased these batteries from NHS Supply Chain, their codes (NPC) are given below:
|NPC (England only)||Manufacturer product code||Description||Brand|
|GHD3582||A675P MF||R44 zinc air size 675 for cochlear implants||ZeniPower|
|GHD3583||A675 MF||R44 zinc air size 675||ZeniPower|
|GHD3584||A13 MF||R48 zinc air size 13||ZeniPower|
|GHD3585||A312 MF||R41 zinc air size 312||ZeniPower|
|GHD3586||A10 MF||R70 zinc air size 10||ZeniPower|
Since 13 January 2016, NHS Supply Chain has received new supplies of batteries, which do not exhibit this problem.
Problem / background
The problem is caused by excessive gassing, as the zinc electrode reacts with the electrolyte to generate hydrogen. The battery may expand and possibly explode on rare occasions. This issue affects all types of ZeniPower mercury-free batteries listed above.
ZeniPower Battery Co. Ltd
Tel: +86 756 252 6620
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- Audiology departments
- Cochlear implant centres
- ENT departments
- ENT medical staff
- ENT services, directors of
- Risk managers
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- Community pharmacists
- General practitioners
- General practice managers
- General practice nurses
Establishments registered with the Care Quality Commission (CQC) (England only)
- Adult placement
- Care homes providing nursing care (adults)
- Care homes providing personal care (adults)
- Domiciliary care providers
- Further education colleges registered as care homes
- Hospitals in the independent sector
- Independent treatment centres
- Nursing agencies
- Private medical practitioners
Establishments registered with OFSTED
- Children’s services
- Educational establishments with beds for children
- Residential special schools
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2016/003 or 2015/012/010/401/016.
Yasser Zayni or Andy Marsden
Tel: 020 3080 7238 or 7205
Mark Grumbridge, MHRA
Senior Clinical Advisor
Telephone: 020 3080 7128
Reporting adverse incidents in England
Alerts in Northern Ireland are distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre
Department of Health, Social Services and Public Safety
Telephone: 028 9052 3868
Fax: 028 9052 3900
Reporting adverse incidents in Northern Ireland
Please report directly to NIAIC using the forms on our website.
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Telephone: 0131 275 7575
Fax: 0131 314 0722
Reporting adverse incidents in Scotland
NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.
Enquiries in Wales should be addressed to:
Healthcare Quality Division
Telephone: 02920 823 624/02920 825 510
Reporting adverse incidents in Wales
Published: 10 March 2016
Issued: 10 March 2016
Alert type: Medical device alert