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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM
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ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM Back to Search Results
Model Number WCD 4000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Date 02/27/2015
Event Type  Injury  
Event Description
A distributor contacted zoll on (b)(6) 2015 to report that a (b)(6) year old female pt alleged that she may have a fractured rib due to the lifevest.There is no indicated that the pt sought med attention for the injury.The pt ended use of the lifevest.
 
Manufacturer Narrative
Electrode belt sn (b)(4) was not returned to the mfr.There is no indication of a device failure associated with this event.Biocompatibility testing to iso (b)(4) was successfully completed on skin-contacting surfaces of the lifevest device as well as the blue defibrillation gel.
 
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Brand Name
LIFEVEST WCD 4000 SYSTEM
Manufacturer (Section D)
ZOLL MANUFACTURING CORPORATION
pittsburgh PA 15238 349
Manufacturer Contact
jeremy silver
121 gamma dr
pittsburgh, PA 15238-3495
4129683333
MDR Report Key4658377
MDR Text Key20153467
Report Number3008642652-2015-01711
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 Distributor
Type of Report Initial
Report Date 03/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberWCD 4000
Was Device Available for Evaluation? No
Date Manufacturer Received03/03/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2014
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 Outcome(s) Other;
Patient Age69 YR
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