MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR

Model Number WCD 4000

Device Problems Defibrillation/Stimulation Problem (1573); Difficult or Delayed Activation (2577)

Patient Problem Death (1802)

Event Date 12/29/2013

Event Type  Death  

Event Description

During a retroactive review of past complaints for potential adverse events, conducted as a capa in response to a recent fda inspection, a reportable adverse event was discovered.On (b)(6) 2012, zoll was notified that a (b)(6) male pt received a treatment following a lengthy period of vt.Zoll contacted the hospital where the pt was admitted.The pt's nurse reported that the pt had been intubated following the lifevest defibrillation.The pt's nurse reported that she thought that the lifevest took too long to administer a treatment, "as over 30 seconds of v-tach were recorded by their telemetry before the treatment took place." another of the pt's nurses reported that the lifevest "appeared to be doing nothing when the pt needed treatment, so she pressed the button on the device to shock him." zoll was notified that the pt received an additional treatment the same day.A third nurse indicated that she "pressed the button on the monitor to administer a treatment." the pt later passed away.

Manufacturer Narrative

Device eval summary: device evaluations of monitor sn (b)(4) and belt sn (b)(4) were completed.Upon eval, the monitor and electrode belt were fully functional.Review of the event reveals that the pt experienced one inappropriate and one appropriate shock during an episode of vt.The first arrhythmia self-converted to sinus bradycardia just prior the treatment.The second arrhythmia was successfully converted to a slower rhythm.Despite the report from the nurses that the "button was pressed to deliver treatment", review of the event reveals that the response buttons were not pressed during the entire event.As the nurses reported, it is likely that only 1 response button was pressed.Pressing only 1 response button does not interrupt or affect the treatment sequence.Zoll explained to the nurses that pressing both response buttons delays a treatment from occurring.Zoll further explained that the lifevest may siren for 60 seconds before treating for vt and that there is no button on the device to force the lifevest to administer a treatment.There is no indication that the lifevest caused or contributed to the pt being intubated.Device mfg date: monitor; belt: 04/2012.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: katelynn mains ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4250072
• MDR Text Key: 5016004
• Report Number: 3008642652-2014-03675
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 74 YR