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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 Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
 
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device displayed a "defib fault 196" message.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The malfunction was duplicated and attributed to a biphasic flex cable that was not seated properly.The cable was reseated.The device was recertified and returned to the customer.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 Key7784799
Report Number1220908-2018-02312
Device Sequence Number173965
Product Code MKJ
UDI-Device Identifier00847946015640
UDI-Public00847946015640
Combination Product (Y/N)Y
Initial Reporter StateAR
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) 07/26/2018
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 Manufacturer08/21/2018
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 07/26/2018
Supplement Date Received by Manufacturer07/26/2018
Initial Report FDA Received Date08/15/2018
Supplement Report FDA Received Date09/17/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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