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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION M SERIES; DEFIBRILLATOR/PACEMAKER
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ZOLL MEDICAL CORPORATION M SERIES; DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number MSERIES CCT
Medical Device Problem Code Failure to Discharge (1169)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device was put through extensive testing without duplicating the report.The rubber shock button cover was replaced as a precaution.The device was recertified and returned to the customer.No trend is associated with reports of this type.
 
Event or Problem Description
Complainant alleged that during functional testing, the device failed to discharge.Complainant did not indicate that there was any patient involvement in the reported malfunction.Complainant indicated that subsequent testing did not duplicate the reported malfunction.
 
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Brand Name
M SERIES
Common Device Name
DEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key7203260
Report Number1220908-2018-00079
Device Sequence Number135339
Product Code MKJ
UDI-Device Identifier00847946006501
UDI-Public00847946006501
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K011865
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/08/2018
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 NumberMSERIES CCT
Device Catalogue NumberM SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2018
Initial Date Received by Manufacturer 01/08/2018
Initial Report FDA Received Date01/18/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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