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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR
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ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number WCD 4000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abrasion (1689); Allergic reaction (1701)
Event Date 07/07/2013
Event Type  Injury  
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) 2013, the wife of a (b)(6) year old male patient contacted zoll customer support to report that the patient had a rash under the back and right electrodes that looks like an allergic reaction.An infectious disease doctor recommended hydrocortisone cream to treat the irritation.There was no follow-up information on the condition of the irritated area.
 
Manufacturer Narrative
Evaluation: biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces of the lifevest device a swell as the blue (tm) defibrillation gel.
 
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Brand Name
LIFEVEST WCD 4000 SYSTEM
Type of Device
WEARABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ZOLL MANUFACTURING CORPORATION
pittsburgh PA 15238 349
Manufacturer Contact
jeremy silver
121 gamma dr
pittsburgh, PA 15238-3495
4129683333
MDR Report Key4262183
MDR Text Key5007871
Report Number3008642652-2014-04059
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
Type of Report Initial
Report Date 11/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2014
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 Received10/31/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age71 YR
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