FDA updates on Zoll Medical LifeVest 4000 error 102 issues

The FDA today updated on a previous voluntary recall of Asahi Kasei (TYO:3407) subsidiary Zoll Medical‘s LifeVest wearable automatic external defibrillators over errors that can cause the device to stop functioning, saying the company has initiated new customer training on the device and is working on a software fix.

In January, the FDA released a warning and Zoll initiated a voluntary recall of the devices after learning of a patient death related to an error code displayed by the vest.

The company, and the FDA, said that patients using LifeVest 4000 models who don’t contact the company after the device displays “Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102” run the risk that it won’t be able to deliver therapy if needed. At the time, the FDA labeled the recall as a Class II recall.

But because the alert “does not explicitly indicate to the patient that the device cannot be used and that the patient should call Zoll immediately,” patients might not realize that their device isn’t operating properly and fail to contact the company, the federal safety watchdog said.

The FDA said today that the company has updated its customer training related to the issue, and now instructs patients on how to handle the error, which includes immediate contact with Zoll to arrange for a replacement device.

Zoll also said it is developing a software design change for the LifeVest with a “new, more prominent and persistent message scheme” for the code, according to an FDA release.

The FDA said the updated training would increase awareness of the issues, and that it will “work expeditiously to review any changes from Zoll that may affect patient safety and will continue to work with Zoll to identify a permanent solution to the Message Code 102 issue.”

The federal watchdog also advised any users of the device to contact Zoll immediately if the error is shown.

In May, Zoll Medical led an undisclosed round of debt financing for oxygen therapy developer TherOx.

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