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U.S. Department of Health and Human Services

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

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ZOLL LIFECOR CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number WCD 4000
Device Problems Self-Activation or Keying (1557); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/17/2013
Event Type  malfunction  
Manufacturer Narrative
Device eval summary: device eval of monitor sn (b)(4) is underway.Upon eval the monitor was resetting during a pulse test.A root cause investigation is underway.A supplemental report will be submitted upon completion of the root cause investigation.No adverse event resulted from the defective monitor.The last patient to use this monitor did not report any deficiencies.
 
Event Description
A review of service data detected a reportable problem.During servicing, monitor sn (b)(4) was intermittently resetting during the pulse test.The last patient to use this monitor did not report any deficiencies.
 
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Brand Name
LIFEVEST WCD 4000 SYSTEM
Type of Device
WEARABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ZOLL LIFECOR CORPORATION
121 gamma dr
pittsburgh PA 15238 000
Manufacturer (Section G)
ZOLL LIFECOR CORPORATION
121 gamma dr
pittsburgh PA 15238 000
Manufacturer Contact
zachary nelson
121 gamma dr
pittsburgh, PA 15238-0000
4129683333
MDR Report Key3653872
MDR Text Key21271796
Report Number3008642652-2014-00180
Device Sequence Number1
Product Code MVK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 01/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberWCD 4000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2013
Is the Reporter a Health Professional? No
Date Manufacturer Received12/17/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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