Download Arkon Anesthesia Delivery System

1 Harforde Court, John Tate Road
Hertford, SG13 7NW
United Kingdom
Tel +44 (0) 1992 507700
Fax +44 (0) 1992 501213
www.spacelabshealthcare.com
17 April 2015
URGENT - MEDICAL DEVICE CORRECTION
Spacelabs Healthcare Ltd.
Arkon Anesthesia Delivery System
Dear Hospital Administrator/Biomedical Manager/Office Manager:
Spacelabs Healthcare would like to inform you about a potential issue with the Arkon
anesthesia delivery system. We have received two reports of the Arkon transformer inrush
PCBA (670-1624-00) failing, causing a loss of power on all auxiliary power outlets. This issue
affects Arkon units configured for 230 volt operation only. All anesthesia monitoring, alarming
and ventilation delivery functions are unaffected by this failure mode and no one has been
injured as a result of this issue. The information contained in this safety notice is intended to
inform you about:
•
•
•
The nature of the problem and the circumstances in which it can occur.
Actions the customer / user can take to minimize risk to patients or users.
Actions implemented by Spacelabs to correct the problem.
Please circulate this notification to all persons affected by the information it contains and add
a copy to the appropriate Arkon user manual until such time as corrections have been
implemented by Spacelabs. Spacelabs will be replacing the affected PCBA at no cost.
As always, patient safety is a top priority at Spacelabs as we partner with you to provide the
best care experience to patients and their families.
We confirm that this notice has been sent to the appropriate regulatory agencies.
Sincerely,
Al Van Houdt

1 Harforde Court, John Tate Road
Hertford, SG13 7NW
United Kingdom
Tel +44 (0) 1992 507700
Fax +44 (0) 1992 501213
www.spacelabshealthcare.com
Sr. Mgr. Regulatory Affairs & Compliance
Spacelabs Healthcare
Affected
System
Description
of Problem
Identification
of Risk
Arkon Anesthesia Delivery System, Model 99999 (230 VAC versions)
Spacelabs has received two reports of the Arkon transformer inrush PCBA (PN: 670-1624-00)
failing prematurely and causing loss of power on all auxiliary power outlets. The failure mode
requires the cumulative auxiliary power outlet load to be in excess of 200 watts. If the inrush
PCBA fails, Anesthesia monitoring, alarming and ventilation delivery will not be affected. No
one has been injured as a result of this issue.
The potential risk is that devices which do not have battery backup and that are plugged into an
auxiliary outlet may lose power. However, the devices could be plugged into a wall outlet rather
than the Arkon unit.
We at Spacelabs recognize and share your concern for patient safety. Please weigh the
benefits versus the risks as well as your ability to deploy alternative devices when deciding
whether or not to continue to use the Arkon anesthesia delivery system.
Actions to be
Implemented
by Users
Corrective
Actions
If you continue to use the affected Arkon anesthesia delivery system:
•
•
Keep the total load on the Arkon auxiliary outlets below 200 watts cumulatively.
If the cumulative load exceeds 200 watts, plug the device(s) into another supply such
as provided in your wall outlets.
To correct this situation, a Spacelabs Healthcare Field Service Engineer will contact you to
arrange for a convenient time to replace the affected transformer inrush PCBA at no cost to
you.
For additional information or technical assistance, please contact:
Information
and Technical
Assistance

Spacelabs Healthcare Ltd. at 1 Harforde Court, John Tate Road, Hertford, SG13 7NW United
Kingdom, telephone No. +44(0) 1992 507725, or email [email protected] for
Technical Support.