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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 Self-Activation or Keying (1557)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/27/2014
Event Type  malfunction  
Event Description
The son of an (b)(6) patient called zoll customer support to report that the patient's charger was resetting.The patient was issued a replacement battery charger/modem.
 
Manufacturer Narrative
Device evaluation summary: device evaluation of battery charger/modem (b)(4) has been completed.The reported problem (resetting) has been confirmed.Upon investigation the battery charger/modem was resetting.The cause for the resets was isolated to a shorted u13 cmos flash microcontroller on the bedside pca board.The root cause for the shorted u13 component could not be positively identified.No adverse event resulted from the defective battery charger/modem.The patient received a replacement battery charger/modem.
 
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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
zachary nelson
121 gamma dr
pittsburgh, PA 15238-3495
4129683333
MDR Report Key3983675
MDR Text Key15821224
Report Number3008642652-2014-01931
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 06/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2014
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? Yes
Date Returned to Manufacturer06/04/2014
Date Manufacturer Received06/05/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age80 YR
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