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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION CPR STAT PADZ; ELETRODE
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ZOLL MEDICAL CORPORATION CPR STAT PADZ; ELETRODE Back to Search Results
Model Number 8900-0400
Device Problem Device Sensing Problem (2917)
Patient Problem Death (1802)
Event Date 08/21/2014
Event Type  Death  
Event Description
Complainant alleged that while attempting to treat a pt the associated defibrillator was unable to obtain an ecg signal via electrode rads.Complainant indicated that the clinician obtained another device to continue treating the pt.Complainant indicated that the pt subsequently expired.
 
Manufacturer Narrative
Zoll medical corp has received the product and will be providing a follow-up report when our investigation is completed.
 
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Brand Name
CPR STAT PADZ
Type of Device
ELETRODE
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
chelmsford MA
Manufacturer Contact
scott august
269 mill road
chelmsford, MA 01824-4105
9784249552
MDR Report Key4176774
MDR Text Key5086846
Report Number1220908-2014-02429
Device Sequence Number1
Product Code MLN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Unknown
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 09/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/25/2015
Device Model Number8900-0400
Device Catalogue Number8900-0400
Device Lot Number4813
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/22/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received09/09/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
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