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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 Unable to Obtain Readings (1516)
Health Effect - Clinical Code No Information (3190)
Date of Event 02/24/2018
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 was unable to obtain an ecg signal via electrode pads.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
 
Additional Manufacturer Narrative
The malfunction was duplicated and the defib receptacle assembly was replaced to resolve the malfunction.Analysis of 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 Key7359871
Report Number1220908-2018-00768
Device Sequence Number11177073
Product Code MKJ
UDI-Device Identifier04560233592995
UDI-Public04560233592995
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K112432
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 03/02/2018
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 Manufacturer03/15/2018
Initial Date Received by Manufacturer 03/02/2018
Supplement Date Received by Manufacturer03/02/2018
Initial Report FDA Received Date03/21/2018
Supplement Report FDA Received Date05/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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