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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); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2013
Event Type  malfunction  
Event Description
A (b)(6) male patient contacted zoll customer support to report that the monitor was making a high pitch sound and switching between screens.The patient was issued a replacement monitor.
 
Manufacturer Narrative
Device evaluation summary: device evaluation of monitor sn (b)(4) is currently underway.The reported problem (high pitched noise / switching between screen) has been confirmed.As received, the monitor was resetting.A root cause investigation is currently underway.A supplemental report will be sent upon completion of evaluation.No adverse event resulted from the defective monitor.The patient received a replacement monitor.
 
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Brand Name
LIFEVEST WCD 4000 SYSTEM
Type of Device
WEARABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ZOLL LIFECOR CORPORATION
pittsburgh PA 15238 349
Manufacturer Contact
katelynn mains
121 gamma dr
pittsburgh, PA 15238-3495
4129683333
MDR Report Key3653502
MDR Text Key4199171
Report Number3008642652-2014-00206
Device Sequence Number1
Product Code MVK
Combination Product (y/n)N
PMA/PMN Number
P010030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Remedial Action Replace
Type of Report Initial
Report Date 01/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? Yes
Date Returned to Manufacturer12/24/2013
Initial Date Manufacturer Received 01/01/2014
Initial Date FDA Received01/16/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age56 YR
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