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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 Unexpected Shutdown (4019)
Health Effect - Clinical Code No Information (3190)
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 while attempting to treat a patient (age & gender unknown), the device inappropriately shut down.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
 
Additional Manufacturer Narrative
The customer's report was observed during initial testing.However, after the device was disassembled to isolate root cause the reported problem could no longer be duplicated.The control board was replaced and scrapped as a precaution.The device was recertified and returned to the customer.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 Key9867048
Report Number1220908-2020-00768
Device Sequence Number19560731
Product Code MKJ
UDI-Device Identifier00847946011420
UDI-Public00847946011420
Combination Product (Y/N)N
Initial Reporter StateWA
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) 03/02/2020
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 Manufacturer03/12/2020
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 03/02/2020
Supplement Date Received by Manufacturer03/02/2020
Initial Report FDA Received Date03/23/2020
Supplement Report FDA Received Date04/28/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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