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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL LIFE VEST; LIFEVEST WEARABLE DEFIBRILLATOR
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ZOLL LIFE VEST; LIFEVEST WEARABLE DEFIBRILLATOR Back to Search Results
Device Problems Device Alarm System (1012); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Cardiac Arrest (1762); Death (1802); Respiratory Distress (2045); Heart Failure (2206)
Event Date 09/22/2015
Event Type  Death  
Event Description
My husband was released from (b)(6) hospital after bypass surgery with a life vest device in lieu of a pace maker.Less than 48 hours later, he was not feeling well and before we could get him back to the hospital he had a cardiac arrest.The vest was recording shockable waves throughout the day but it did not alarm until after the cardiac arrest occurred and it did not ever shock him.I have the hospital records listing the kinds of waves the vest was reporting and the fact that it only alarmed once after the cardiac arrest and did not shock.We thought he was relatively healthy until he developed a resistant cough.Saw a doctor in (b)(6) was told he just has acid reflux - put on prilosec.Condition worsened, saw another doctor in august was told the cough was due to heart failure.Hospitalized, bypass surgery performed, released from hospital with life vest, had cardiac arrest.He was dead.
 
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Brand Name
LIFE VEST
Type of Device
LIFEVEST WEARABLE DEFIBRILLATOR
Manufacturer (Section D)
ZOLL
MDR Report Key6338812
MDR Text Key67813776
Report NumberMW5067921
Device Sequence Number1
Product Code MKJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 02/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age67 YR
Patient Weight68
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