Bertec Model FLH668NDCM Medical Beds - Recall due to the Potential for the Head or Foot Section to Drop Unexpectedly - Notice to Hospitals

Starting date:

March 9, 2011

Posting date:

April 6, 2011

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002424

This is duplicated text of a letter from Stryker Canada.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Notice to Hospitals - Health Canada Endorsed Important Safety Information on Bertec Medical Bed Model FLH668NDCM

March 9, 2011

Dear Risk Manager/Facilities Administrator/Biomed Engineer:

Please distribute to relevant Departments (Biomedical Engineering, Surgery, Emergency Medicine, Paediatrics, Anaesthesia, Geriatrics, Internal Medicine, Nursing, Intensive Care and/or other Departments as required), and other involved professional staff and post this Notice in your institution.

Subject: Recall of Medical Bed Model FLH668NDCM with potential for head or foot section to drop unexpectedly

Stryker Medical would like to notify you of a potential situation regarding the "screw box" on the Bertec Model FLH668NDCM beds for which a relevant Canadian incident was reported to Health Canada. While no injuries have occurred, we have identified the potential for either the head section or the foot section of the bed to drop unexpectedly, if preventive maintenance has not been conducted, as specified in the owner's manual. The owner's manual included instructions for the annual cleaning and lubrication of the screw box. The potentially affected units were manufactured more than 10 years ago. While the units are currently beyond their intended life, we are taking this opportunity to notify users, as they may still be in-use.

Immediate Action Required:

• Complete and return the attached Accountability Form to fax # 905-690-5718 or email it to CARAQA@stryker.com.
• Review the maintenance records for FLH668NDCM beds at your facility and verify that appropriate maintenance has been conducted throughout the product life;
• If maintenance records are not available or incomplete, locate the beds specified in this notice and visually inspect the screw box to ensure that:
  • There is no hardening of the grease on the screw, and;
  • There are no cracks of the screw box.
  • If grease is hardened or cracks are identified, we recommend that you take the product out of service.

Should you have any further questions or concerns, please do not hesitate to contact Stryker Medical at 1-905-690-5700 ext. 2198, or via e-mail at CARAQA@stryker.com.

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 related to FLH668NDCM medical beds should be reported to Stryker Canada or Health Canada at the following addresses:

Stryker Canada

45 Innovation Drive

Hamilton, Ontario

L9H 7L8

Toll: 1-800-668-8324

Any suspected adverse incident 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 Guidelines can be found on the Health Canada Web site.

For other medical device inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate

E-mail: mhpd_dpsc@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

To change your mailing address or fax number, contact the Market Authorization Holder (Industry).

original signed by

Nicole Khanna

Quality Assurance & Post Market Vigilance

PRODUCT CORRECTION ACCOUNTABILITY FORM

March 9, 2011

Internal Reference# RA 2011-044 [Correction Date: March 9, 2011]

Description: Medical Bed Model FLH668NDCM

Hospital:

Please complete and return this form immediately to fax# 1-905-690-5718 or email to CARAQA@stryker.com.

I have received the notification from Stryker dated March 9, 2011 stating that they have initiated a product correction for the above referenced product.

• No, we have physically checked all inventory and hospital locations and we DO NOT have any affected Product[s].
• Yes, we have checked our hospital and have located # of affected products and will review the maintenance records for these units.

COMMENTS:

(Signature) Risk Manager/Facilities Administrator/Biomed Engineer:

Date:

Hospital (Print):

Date: