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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 Power Up (1476)
Health Effect - Clinical Code No Information (3190)
Date of Event 06/21/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The reported malfunction was observed and attributed to the lithium coin battery on the system board.The device was recertified and returned to the customer.Zoll medical corporation recommends replacement of the lithium battery on the system board every 5 years.This device is approximately 9 years old from date of manufacture.Analysis of reports of this type has not identified an increase in trend.
 
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device would not power up.Complainant did not indicate that there was any adverse effect to the patient due to 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 Key8784186
Report Number1220908-2019-01929
Device Sequence Number1668037
Product Code MKJ
UDI-Device Identifier00847946009502
UDI-Public00847946009502
Combination Product (Y/N)N
Initial Reporter StateAL
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) 06/24/2019
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 Manufacturer07/03/2019
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/24/2019
Initial Report FDA Received Date07/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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