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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION E SERIES DEFIBRILLATOR
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ZOLL MEDICAL CORPORATION E SERIES DEFIBRILLATOR Back to Search Results
Model Number E SERIES
Medical Device Problem Code Device Operational Issue (2914)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
 
Event or Problem Description
Complainant alleged that during incoming inspection, the device powered up in the incorrect mode.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The malfunction was duplicated and the front panel membrane was replaced to resolve the malfunction.Analysis of reports of this type has not identified an increase in trend.
 
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Brand Name
E SERIES DEFIBRILLATOR
Common Device Name
E SERIES
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key7157853
Report Number1220908-2017-03303
Device Sequence Number18867059
Product Code MKJ
UDI-Device Identifier00847946015435
UDI-Public00847946015435
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K042007
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/13/2017
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
Operator of Device Other
Device Model NumberE SERIES
Device Catalogue NumberE SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2017
Initial Date Received by Manufacturer 12/13/2017
Supplement Date Received by Manufacturer12/13/2017
Initial Report FDA Received Date01/02/2018
Supplement Report FDA Received Date01/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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