Notice regarding product of Asahi Kasei’s US subsidiary ZOLL
Asahi Kasei Corp.
Asahi Kasei hereby issues the following notice with respect to a Safety Communication issued by the United States Food and Drug Administration (FDA) on January 17, 2018 (US Eastern time) regarding a product of ZOLL Medical Corporation.
Product:
LifeVest 4000 Wearable Cardioverter Defibrillator
Essence of FDA Safety Communication:
The communication outlines information and recommendations regarding the ZOLL LifeVest 4000 due to concerns that the device may fail to deliver treatment to a patient if the device is not replaced soon after displaying a “Call for service — Message Code 102”. It is very rare for a “Call for service — Message Code 102” to be associated with a device issue that would prevent the device from being able to deliver a treatment shock. Additionally, this code can be displayed for reasons that do not impact the device’s ability to deliver a treatment shock.
Response by ZOLL:
In response to this rare, but potentially serious situation, ZOLL decided to modify the instructions for patients if a “Call for service — Message Code 102” is displayed on the LifeVest device. In the event this code is displayed, patients are instructed to call ZOLL immediately for a replacement LifeVest. A replacement device will be provided within 24 hours.
This is not a physical recall of the product. In this instance, the FDA is referring only to a change in patient training.
ZOLL has been in close communication with the FDA on this issue, and Asahi Kasei believes that there will be no significant impact on the LifeVest business or Asahi Kasei’s consolidated financial performance.