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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 BI-PHASIC
Medical Device Problem Code Failure to Power Up (1476)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
 
Event or Problem Description
Complainant alleged that during functional testing, the device would not power up.Complainant did not indicate that there was any patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The malfunction was duplicated and the system board was replaced to resolve the malfunction.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
 
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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 Key7593631
Report Number1220908-2018-01620
Device Sequence Number18873788
Product Code MKJ
UDI-Device Identifier00847946013691
UDI-Public00847946013691
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
K990762
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) 05/23/2018
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 BI-PHASIC
Device Catalogue NumberM SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2018
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 05/23/2018
Supplement Date Received by Manufacturer05/23/2018
Initial Report FDA Received Date06/12/2018
Supplement Report FDA Received Date08/11/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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