Alarms are used in many areas to protect homes and businesses, and the medical field relies on efficient alarms to send warnings in many cases. In the medical field, remote alarms are depended on to protect patients from injury or death. Smiths Medical ASD, Inc. has announced that in certain instances their BCI Remote Alarm Cables are not transferring the alarm that identifies that a patient is in distress. The Food and Drug Administration (FDA) has determined this to be a serious malfunction in the alarm.
The problem was discovered in the cables that are used with the 9004 Capnocheck Capnography System, which is used in critical areas of the medical field. This type of the alarm is used with patients on ventilator applications, in situations where anesthesia is required and especially in patient transport. The Capnocheck System is a remote alarm system, which requires BCI remote cables to relay the signal to the receiver when activated, and in rare instances this was not occurring.
On February 6, 2013, Smiths Medical sent out an “Urgent Medical Device Field Safety Notice-Recall” letter to their customers to announce this defect. The letter was sent via UPS along with instructions to follow 3 steps: 1) inspect and test their inventory 2) remove alarms that were found to be defective and 3) complete the “Confirmation Form,” by faxing it to 800-237-8033. This recall was issued so all buyers could take action to prevent anyone from not receiving the emergency care because the alarm was not transmitted. The recall letter did not state when this malfunction was discovered or when it was reported to the company.
Healthcare personnel who use the Capnocheck Capnography System are encourage to report any conflicting or negative reactions that they have with the equipment in their facility. The comments are being evaluated by the Adverse Event Reporting Program and the MedWatch Safety Information, both of which are operated by the FDA. All reports can be submitted online at the FDA website, www.fda.gov/MedWatch/report.htm. The form may also be downloaded and faxed to 800-FDA-0178. This recall encourages quick and urgent response from the buyers because of its significant nature.