Asahi Kasei (TYO:3407) subsidiary Zoll Medical and the FDA are warning about an error code displayed by a model of its LifeVest wearable automatic external defibrillator that was involved in a patient’s death.
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, according to the FDA, which put a Class II recall label on the action.
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.
There were 33,670 of the devices distributed worldwide as of Nov. 14, 2017, some 25,000 of them in the U.S., Zoll told the FDA. Roughly 0.1% of the total devices distributed have displayed Message Code 102, the agency said, noting that the message “should only be remedied by immediate replacement of the device.” The FDA said it’s “aware of one patient death due to the LifeVest’s failure to deliver treatment as expected after Message Code 102 was displayed.”
A safety alert last September from Zoll revised the training for physicians, caregivers and patients about the call-for-service message, advising them to contact the company immediately if the message is displayed on their LifeVest device. Zoll pledged to replace any such devices within 24 hours.