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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 of Device to Self-Test (2937)
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 functional testing, the device intermittently failed self-test.Complainant did not indicate that there was any patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
A zoll medical representative went on site and evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing which included all functional testing without duplicating the malfunction.Review of the device activity logs did not show any faults that could be associated with customer report.No trend is associated with reports of this type.
 
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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 Key9038789
Report Number1220908-2019-02688
Device Sequence Number2487703
Product Code MKJ
UDI-Device Identifier00847946016685
UDI-Public00847946016685
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K042007
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 08/23/2019
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 Other
Device Model NumberE SERIES
Device Catalogue NumberE SERIES
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 08/23/2019
Supplement Date Received by Manufacturer08/23/2019
Initial Report FDA Received Date09/13/2019
Supplement Report FDA Received Date10/22/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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