Hospital Wearable Defibrillator HWD 1000 Battery ChargerRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00855778005173), received between Mar 2, 2021 and Apr 12, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Charge” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2022Failure to Charge

  A US DISTRIBUTOR REPORTED THAT A BATTERY CHARGER WAS UNABLE TO CHARGE A BATTERY.

  Patient problems: Insufficient Information

  MAUDE report 14085832 ↗
• MalfunctionMar 19, 2022Failure to Power Up

  CJ 6.13

  Patient problems: Insufficient Information

  MAUDE report 13825073 ↗
• MalfunctionMar 2, 2021Patient-Device Incompatibility

  A US DISTRIBUTOR REPORTED THAT A BATTERY CHARGER WAS RESETTING.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 11399469 ↗

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.