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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER
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ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number X SERIES
Medical Device Problem Code Device Displays Incorrect Message (2591)
Health Effect - Clinical Code No Patient Involvement (2645)
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 during incoming testing, the device displayed an unknown defib error.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The device was returned to zoll medical corporation; the malfunction was duplicated and attributed to a faulty integrated circuit on the processor/bridge/pace board.Analysis for reports of this type has not identified an increase in trend.
 
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Brand Name
X SERIES
Common Device Name
DEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key7500356
Report Number1220908-2018-01255
Device Sequence Number16690013
Product Code MKJ
UDI-Device Identifier00847946018139
UDI-Public00847946018139
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K112432/P160
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) 04/19/2018
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 NumberX SERIES
Device Catalogue NumberX SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2018
Initial Date Received by Manufacturer 04/19/2018
Supplement Date Received by Manufacturer04/19/2018
Initial Report FDA Received Date05/09/2018
Supplement Report FDA Received Date05/22/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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