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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 No Display/Image (1183)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/27/2019
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 male patient (age unknown) for cardiac arrest, the device's screen turned completely multicolored and was illegible.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
 
Additional Manufacturer Narrative
The customer report was observed during testing.However, it was unable to be duplicated when trying to isolate root cause.The display cable was replaced as a precaution.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 Key9226695
Report Number1220908-2019-03210
Device Sequence Number16187337
Product Code MKJ
UDI-Device Identifier00847946009670
UDI-Public00847946009670
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,Followup
Report Date (Section B) 10/02/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2019
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 10/02/2019
Supplement Date Received by Manufacturer10/02/2019
Initial Report FDA Received Date10/23/2019
Supplement Report FDA Received Date11/06/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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