MAUDE Adverse Event Report: ZOLL LIFECOR EXTERNAL DEFIBRILLATOR VEST

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Sleep Dysfunction (2517)

Event Date 05/30/2015

Event Type  malfunction  

Event Description

Complaint against the zoll external defibrillator.On (b)(6) 2015, i visited a new cardiologist.He told me that i was in danger of sudden death due to the condition of my heart.He wanted to do surgery immediately to install a defibrillator pacemaker.I advised him that due to poor insurance coverage, i could not have surgery until (b)(6).I advised him that i was in no position to take on the financial debt for treatment until (b)(6).The doctor insisted that i must be fitted with an external defibrillator.On (b)(6) 2015, (b)(4), working for zoll lifecor, contacted me with an order from this doctor.She came to my house, fitted me with an external defibrillator vest, instructed me on how it worked.If the buzzer signaled, i was to press a button to prevent getting a powerful shock intended to restart the heart.I must remove the vest, then contact zoll tech support for assistance.Overwhelmed and skeptical about the need for this equipment, i asked (b)(4) about the cost.She gave me nothing.Shortly after she left, the equipment sounded.Removing it as instructed, i contacted zoll tech support, following instructions to make sure that four round leads were flat against the body.Yet, the vest continued to signal.I called tech several times trying to stop the alert.I was told to clean each lead with alcohol, to change the battery, but nothing helped.The device repeatedly alerted.Threat of being shocked terrified me.During the night, i was startled from sleep several times, forced to jump up, press the button, remove the vest and try to figure out why it alerted.The next day, i contacted (b)(4) advising her of all of the problems.Nothing she said helped to quiet the vest.Another zoll representative advised me to put unscented lotion on the leads to make contact.She also unscrewed and reattached a cord on the vest.But, nothing corrected this menace which nightly robbed me of sleep, while restricting my waking hours.The vest had become impossible to wear.Many calls were made to zoll tech support and to (b)(4).She fitted me with a different size vest, replaced the batteries, but nothing quieted the threat of being shocked.Zoll tech support asked me to upload data to them from a modem different times when i called for help.My heart was not the problem; rather their life vest was malfunctioning.I quit wearing the vest after (b)(6) 2015.Sleep deprivation could no longer be tolerated.The need to regain solace, to put a stop to this dysfunctional medical device drove my decision to remove it.During this time, i made every attempt to resolve issues with the failing, problematic zoll life vest.I fretted that the doctor would refuse to help me if i defied his order to wear this equipment.Conflicted about what to do, zoll was eventually contacted.(b)(6) would pick up the equipment.The return was followed by phone calls, as well as correspondence to zoll and to (b)(6).After confronting the doctor who ordered this "life vest", he admitted that this order was to protect him from lawsuit.He wrote a letter stating that the equipment was ineffective for me and that i should not have to pay for it, yet the insurance company, (b)(6), continues to bill me through (b)(6) for nearly (b)(6) for this failed equipment.How demoralizing to feel manipulated into taking on this problematic medical device followed by undisclosed, unreasonable debt.I have discovered that many unsuspecting, vulnerable heart patients have complained about a similar scenario involving the zoll life vest.A complaint site is posted on the internet under zoll lifecor.Dates of use: (b)(6) 2015.Event abated after use stopped or dose reduced: no.

• Brand Name: EXTERNAL DEFIBRILLATOR VEST
• Type of Device: EXTERNAL DEFIBRILLATOR VEST
• Manufacturer (Section D): ZOLL LIFECOR
• MDR Report Key: 5630012
• MDR Text Key: 44571666
• Report Number: MW5062060
• Device Sequence Number: 1
• Product Code: MKJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 76