Urgent Medical Device Correction: Liko Uno Patient Lift - For Health Professionals

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Contact: Marketed Health Products Directorate (MHPD)

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The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Hill-Rom.
Contact the company for a copy of any references, attachments or enclosures.

Health Canada Endorsed Important Safety Information on
Liko Uno Patient Lift

November 11, 2008

Subject:

Urgent Medical Device Correction: Liko Uno Patient Lift

FSCA-identifier: Mod 403
Type of action: Device Modification

To: Facility Risk Manager/Facility Administrator

Affected Devices:

MODELS:
Uno 100 EM, Uno 100 EE, Uno 101, Uno 102, Uno 102 EM, Uno 102 EE, and Uno 102 ES

RANGE OF SERIAL NUMBERS AFFECTED:
Uno 100: 7090001-7096200
Uno 101: 10001-11000
Old Uno 102: 20001-21300
New Uno 102: 30001-48100

PRODUCTION DATES:
Manufactured prior to June 26, 2008

Background:

Liko, a Hill-Rom company, has initiated a field correction program for the Liko Uno Patient Lift, applicable only to the models and serial numbers listed above.

The actuator of the lift has the potential to separate when the upper arm is fully extended (see photo). If this happens when a patient is being lifted the lift will fail, resulting in a patient fall.

To date, Liko has received 18 reports of actuator failures, one report of a death from complications associated with a hip fracture, and one report of a fractured femur.

Action to be taken:

Immediately take the unit out of service and contact your authorized Liko distributor or Hill-Rom to discuss available options.

Transmission of this Field Safety Notice:

Please forward a copy of this letter to any other facility personnel you deem appropriate.

If you have any questions concerning this request, please contact Hill-Rom Technical Support using the attached listing for your geographic region.

Hill-Rom
Telephone: 1-800-267-2337
E-mail: jeff.moorehead@hill-rom.com
Distributor Peridot Medical
Telephone: 905-541-1798
E-mail: thuxley@sympatico.ca

Any suspected adverse reaction can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline 1-800-267-9675

The Medical Devices Problem Report Form and the Guidelines can be found on the Health Canada web site.

For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Regards,

Hill-Rom Technical Support

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Technical Support Contact Information

Important: This is a comprehensive list of Technical Support contact information for Hill Rom offices worldwide. If this is attached to another document or letter, it does not mean that every country listed below is affected by that document.

AUSTRIA:
Telephone: 0810 00 10 23 - Fax: + 43 (0)224 32 85 50 - 19
e-mail: austria@hill-rom.com

CANADA:
Telephone: 800-267-2337  (8 am - 5 pm ET (New York time))
e-mail: jeff.moorehead@hill-rom.com
Telephone: 905-541-1798  distributor Peridot Medical
e-mail: thuxley@sympatico.ca

CENTRAL & EASTERN EUROPEAN REGION:
Telephone: +48 (0)692 414 826 - Fax: +44 (0)870 137 1872
e-mail: karolina_fenicka@hill-rom.com

FRANCE:
Telephone: +33 (0)4 73 86 92 05 - Fax: +33 (0)4 73 86 92 05
e-mail: claude_martin@hill-rom.com

GERMANY:
Telephone: +49 (0)2152 144 255 - Fax: +49 (0)2152 144 105
e-mail: germany.customer.care@hill-rom.com

IRELAND:
Telephone: +353 (0)1 413 6005 - Fax: +353 (0)1 413 6050
e-mail: dublin.sales@hill-rom.com

ITALY:
Telephone: +39 02 950542 95 - Fax: +39 02 950543 26
e-mail: assistenza_tecnica@hill-rom.com

MIDDLE EAST & AFRICA REGION:
Telephone: +9714 (0)4-8816818 - Fax: +9714(0)4-8812357
e-mail: trescilla_dsouza@hill-rom.com

NETHERLANDS:
Telephone: +31 (0)347 32 35 32 - Fax: +31 (0) 347 32 35 00
e-mail: info_nl@hill-rom.com

NORDIC REGION: (SWEDEN, NORWAY, DENMARK, FINLAND, ICELAND)
Telephone: +46 (0)8 564 353 60 - Fax: +46 (0)8 564 353 61
e-mail: se.marketing@hill-rom.com.se

SPAIN:
Telephone: +34 (0)902 193 423 - Fax: +34 (0)93 666 55 70
e-mail: asistencia@hill-rom.com

SWITZERLAND:
Telephone: 0848 81 15 30 - Fax: + 41 (0)21 7062132
e-mail: swiss_hotline@hill-rom.com

UNITED KINGDOM:
Telephone: +44 (0)1530 411000 - Fax: +44 (0)1530 562029
e-mail: uk.customer.care@hill-rom.com

UNITED STATES:
Telephone: 800-445-3720 (8 am - 5 pm ET (New York time))

All other countries for support of products manufactured in the US:
Telephone: 812-934-1348 (8 am - 5 pm ET (New York time))
e-mail: gary.lakes@hill-rom.com

All other countries for support of products manufactured outside the US:
Telephone: +33 (0)2 97 50 92 45
e-mail: leny.rodriguez@hill-rom.com