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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 Failure to Discharge (1169)
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 follow-up report when our investigation is completed.
 
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device failed to discharge.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The reported malfunction was observed and attributed to the multi-function cable connector not seated properly to the connector panel.The multi-function cable connector was reseated to remedy the problem.Analysis for 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 Key6529401
Report Number1220908-2017-00914
Device Sequence Number19053754
Product Code MKJ
UDI-Device Identifier00847946011284
UDI-Public00847946011284
Combination Product (Y/N)N
Initial Reporter StateOR
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) 04/07/2017
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 Manufacturer04/26/2017
Type of Report(Section G)FDA Requested
Initial Date Received by Manufacturer 04/07/2017
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date04/28/2017
Supplement Report FDA Received Date05/09/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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