Safety information and corrective action on Air-Shields Isolette C2000/C2000e Infant Incubator - Notice to Hospitals

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Contact: MHPD

NOTICE TO HOSPITALS - Health Canada Endorsed Important Safety Information on Airshields Isolette Infant Incubator C2000

November 17, 2006

From: Draeger Medical Canada Inc. - Regulatory Department

IF YOU HAVE ALREADY RESPONDED TO PREVIOUS NOTICES PLEASE DISREGARD THIS COMMUNICATION

Please distribute to Department of Biomedical and Clinical Engineering, NICU and other professional staff and post this notice in your institution.

Subject: Modification of Air-Shields^® Isolette^® C2000/C2000e Infant Incubator controller if display screen blanking occurs

Dear valued Customer,

Draeger Medical Canada has initiated a recall in accordance with the Canadian Medical Device Regulations of the Air-Shields^® Isolette^® C2000/C2000e Infant Incubator, Model: C2HS (-X), manufactured on or after May 1st 2002.

Some Controllers may experience intermittent or permanent display screen blanking associated with partial disconnects at U11 on the CPU Board and/or the 50-conductor cable connecting the interface and CPU Boards.

The clinical effect of display loss is variable. If the screen blanking is intermittent, there may be no effect at all, or the device may reset and run as intended, or the unit may fail to reset and an alarm indicating system failure will notify the caregiver. In each case that we have investigated, the device provides an audible alarm when this failure occurs. There has been no serious patient injury related to this device failure.

We recommend the following:

We would like to inform you that the "display blanking" issue in the Air-Shields^® Isolette^® C2000/C2000e Infant Incubator has been solved and the solutions are announced below.

Beginning the 1st week of April 2006, each C2000 has been manufactured using an improved controller (identified as serial number RA23802 or higher), that eliminates the display blanking issue. Only C2000's in the field that experience this failure need to be upgraded. We have a field modification kit defined (part number MU18355) for these C2000's.

Please follow these 2 important steps:

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse incidents for medical devices in patients using Draeger Medical products should be reported to Draeger Medical Canada or Health Canada at the following addresses:

Thank you very much for your understanding and cooperation.

Sincerely,

original signed by

Andreas Mueller
Director of Quality and Regulatory Affairs

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Customer Reply Form

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To: Andreas Mueller
Departement: Quality and Regulatory Affairs
Company: Draeger Medical Canada Inc.
Fax: 905.763.1890
Phone.: 1(866)343-2273, 905.763.3702

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Subject: Airshields Isolette C2000 Display blanking

(PLEASE FILL IN BELOW)

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Customer:

Telephone:

Email:

Address:

Address Line 2:

City:

Province:

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(PLEASE FILL IN BELOW)

I, ____________ have received and understand the recall information.
(PLEASE PRINT)

Title:

Signature:

Date:

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(PLEASE FILL IN BELOW)

We have Draeger Medical / Airshields products: Yes   No 

Serial numbers of:

Incubators:

Jaundice Meters:

Open Warmers:

Phototherapy Lights:

Ventilators:

We have experienced above mentioned failure: Yes   No 

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DMS PQ2020 A52, RI01, effective date: 2006-11-06