Hospital Wearable Defibrillator HWD 1000 MonitorRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00855778005159), received between Apr 23, 2020 and Dec 15, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (5 reports).

6 other recalls cover devices cleared under the same FDA submission (P010030); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2021Signal Artifact/Noise; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation

  THE PATIENT WAS INAPPROPRIATELY TREATED ONE TIME. THE PATIENT'S NEUROLOGICAL STATUS AT THE TIME OF THE EVENT IS UNKNOWN. MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. NO INJURY WAS REPORTED FROM THE TREATMENT. NO DEFICIENCIES WERE ALLEGED AGAINST THE DEVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 13013006 ↗
• InjurySep 8, 2021Signal Artifact/Noise; Inappropriate/Inadequate Shock/Stimulation; Use of Device Problem

  THE PATIENT WAS INAPPROPRIATELY TREATED THREE TIMES. THE PATIENT'S NEUROLOGICAL STATUS AT THE TIME OF THE EVENT IS UNKNOWN. INTERFERENCE AND ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. NO INJURY WAS REPORTED FROM THE TREATMENT. NO DEFICIENCIES WERE ALLEGED AGAINST THE DEVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 12443474 ↗
• InjuryJul 30, 2021Signal Artifact/Noise; Inappropriate/Inadequate Shock/Stimulation

  A DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT WAS INAPPROPRIATELY TREATED ONE TIME. THE PATIENT'S NEUROLOGICAL STATUS AT THE TIME OF THE EVENT IS UNKNOWN. MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE PRESSED AFTER THE TREATMENT WAS DELIVERED. THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. NO INJURY WAS REPORTED FROM THE TREATMENT. NO DEFICIENCIES WERE ALLEGED AGAINST THE DEVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 12252064 ↗
• InjuryJun 11, 2021Inappropriate/Inadequate Shock/Stimulation

  THE PATIENT WAS INAPPROPRIATELY TREATED 1 TIME BY THE HOSPITAL WEARABLE DEFIBRILLATOR (HWD). THE PATIENT'S NEUROLOGICAL STATUS AT THE TIME OF THE EVENT IS UNKNOWN. MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE PRESSED AFTER THE TREATMENT WAS DELIVERED. THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. NO INJURY WAS REPORTED FROM THE TREATMENT. THE PATIENT WAS IN THE HOSPITAL AT THE TIME OF THE EVENT. NO DEFICIENCIES WERE ALLEGED AGAINST THE DEVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 11986319 ↗
• InjuryApr 23, 2020Inappropriate/Inadequate Shock/Stimulation

  A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT CONSISTING OF ONE SHOCK WHILE USING A HOSPITAL WEARABLE DEFIBRILLATOR (HWD). THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 9990546 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010030. One submission often covers many models, so check the product and lot details in each record.

• Z-0353-2018 · Sep 12, 2017 · Terminated
  LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac
• Z-0625-2011 · Sep 24, 2010 · Terminated
  Model 4000 Monitor component of the LifeVest Wearable Defibrillator
• Z-0883-2009 · Oct 21, 2008 · Terminated
  Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monitor. The LifeVest is indicated for adult patients who are at
• Z-0061-2008 · Sep 14, 2007 · Terminated
  Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA).
• Z-0936-2007 · Apr 27, 2007 · Terminated
  Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy Electrode Pads attached to the Electrode Belt.
• Z-0578-03 · Jan 10, 2003 · Terminated
  Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI.