Medical device alert: external temporary cardiac pacemaker (bedside model 4170 serial numbers 1 - 998) - return these to manufacturer and ensure rapid pace switch is off before you shut the device down

(APC Medical Ltd) the manufacturer has found potential for rapid pacing while switching off this temporary pacemaker. (MDA/2007/095)

06 December 2007 at 14:30

MDA/2007/095

Action deadlines for the Safety Alert Broadcast System (SABS)

Deadline (action underway): 17 December 2007, Deadline (action complete): 06 June 2008

Device

External temporary cardiac pacemaker. Bedside model 4170 serial numbers: 1 - 998. Manufactured by APC Medical Ltd.

The APC Bedside model 4170 single chamber external temporary cardiac pacemaker is designed in the USA by Pace Medical Inc., produced in the UK by APC Medical Ltd and supplied to UK hospitals by APC Cardiovascular.

Problem

Patients may receive inappropriate fast rate pacing when this temporary pacemaker is being switched off.

Following the investigation of a returned Bedside model 4170 temporary cardiac pacemaker, the manufacturer has concluded that there is a potential for rapid pacing to occur when shutting off the device. This can only occur if there is a failure of a specific electronic component within the pacemaker box, and the rapid pace switch is left on.

APC Medical Ltd issued an Advisory Notice on 09 November 2007 to all affected UK centres.

The manufacturer has developed a software modification to eliminate the possibility of rapid pace pulses from occurring on shutdown. They have requested that all affected pacemakers are returned to them for appropriate upgrade. The temporary cardiac pacemaker can be used while awaiting upgrade provided the rapid pace switch is off when shutting down the device.

Action

  • Check that the rapid pace switch is turned off before shutting down the device.
  • Identify all pacemakers with serial numbers 1 - 998 and return to APC Medical Ltd for a software upgrade.
  • Contact APC Medical Ltd customer service department for information on how to schedule the return of your device(s) for upgrade.

Action by

Electro–biomedical engineering (EBME) departments.

All clinical staff managing patients supported by affected devices.

Distribution

Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:

SABS liaison officers for onward distribution to all relevant staff including:

  • A & E departments
  • Adult & paediatric intensive care units
  • All wards
  • Cardiothoracic surgeons
  • Clinical governance leads
  • Consultant cardiologists
  • Coronary care units
  • Directors of anaesthetics
  • Directors of nursing
  • Directors of paediatric medicine
  • EBME / clinical engineering departments
  • Health & safety officers
  • Medical directors
  • Risk managers
  • Theatre managers

Healthcare Commission (CHAI) to:Headquarters for onward distribution to: Headquarters for onward distribution to:

  • Hospitals in the independent sector

Primary care trusts to: SABS liaison officers for onward distribution to all relevant staff including:

  • Clinical governance leads
  • Community hospitals

Contacts

Enquiries to the manufacturer should be addressed to:

Steven Hanson
APC Medical Ltd
68 Tewin Road
South Mundells Industrial Estate
Welwyn Garden City
Herts
AL7 1BD

Tel: 01707 327 641
Fax: 01707 333 117

E-mail: Pacemedicalpres@aol.com

Enquiries to the MHRA should quote reference number 2007/006/005/401/014 and be addressed to:

Technical aspects

Catherine Scanlan or Hazel Randall
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3223 / 3287
Fax: 020 7084 3106

E-mail: catherine.scanlan@mhra.gsi.gov.uk & hazel.randall@mhra.gsi.gov.uk

Clinical aspects

Dr Christopher Brittain
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3126
Fax: 020 7084 3111

E-mail: christopher.brittain@mhra.gsi.gov.uk

Change of address or removal from address list for Healthcare Commission:

Healthcare Commission
Finsbury Tower
103-105 Bunhill Row
London
EC1Y 8TG

Tel: 020 7448 0842

E-mail: contacts@healthcarecommission.org.uk

How to report adverse incidents

Incidents relating to medical devices must be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) as soon as possible.

Further information about reporting incidents; online incident reporting facilities; and downloadable report forms are available from MHRA’s website (http://www.mhra.gov.uk).

Alternatively, further information and printed incident report forms are available from:

MHRA Adverse Incident Centre
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

Telephone 020 7084 3080 or Fax 020 7084 3109 or e-mail: aic@mhra.gsi.gov.uk(An answerphone service operates outside normal officer hours)

Medical Device Alerts are available in full text on the MHRA website:http://www.mhra.gov.uk

Further information about SABS can be found at www.info.doh.gov.uk/sar2/cmopatie.nsf

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