Important Safety Alerts

Medical device manufacturer, Philips Healthcare, has issued a medical device safety alert concerning its chest pneumograph, NM, 3160 [Part Number: 94023].

According to the manufacturer, the chest pneumograph contains 90-95% natural rubber latex in the tubing that extends from the bellows to the wireless oxygen saturation/pulse oximetry (SpO2) module or gating unit. The chest pneumograph is not labeled as containing natural rubber latex.

Natural rubber latex is a known allergen that may impact the patient or user due to contact with the device against bare skin. The chest pneumograph is expected to be used over a gown or clothing, but there is the possibility of the natural rubber latex tubing contacting the patient's bare arm/leg, patient's bare torso (if no clothing is present), or the user's hands/arms during patient preparation. Allergen related issues could range from minor (irritation or rash) to major (anaphylactic shock).

The manufacturer will provide one kit per chest pneumograph in each user's possession for the purposes of labeling each affected chest pneumograph.

Affected users are advised to take the following actions:

• Review the Field Safety Notice with all members staff who utilize the affected product.
• Retain a copy with the equipment Instructions for Use.
• The chest pneumograph can continue to be used for monitoring as directed by a physician.
• Upon receipt of the kit, follow the included instructions to label each chest pneumograph. The label to be added identifies the product as containing latex.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 27 April 2020