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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 Codes Failure of Device to Self-Test (2937); Output Problem (3005)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was returned to zoll medical corporation.The reported malfunction was observed during testing.However, the reported problem could be duplicated.The device was disassembled and reassembled without duplicating the malfunction.System interconnection flex cables were replaced as a precaution.The device was recertified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.
 
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device failed self-test and the defib output was out of specification.Complainant indicated that there was no patient involvement in the reported malfunction.
 
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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 Key9150201
Report Number1220908-2019-02964
Device Sequence Number2563652
Product Code MKJ
UDI-Device Identifier00847946008710
UDI-Public00847946008710
Combination Product (Y/N)N
Initial Reporter StateFL
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
Report Date (Section B) 09/12/2019
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 Health Professional
Device Model NumberE SERIES
Device Catalogue NumberE SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2019
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/12/2019
Initial Report FDA Received Date10/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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