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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
The customer's report was duplicated and attributed to a faulty integrated circuit on the system board.The system board was replaced.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
 
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device would not power up.Complainant indicated that there was no patient involvement in 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 Key9812531
Report Number1220908-2020-00620
Device Sequence Number778361
Product Code MKJ
UDI-Device Identifier00847946003623
UDI-Public00847946003623
Combination Product (Y/N)N
Initial Reporter StateNY
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
Report Date (Section B) 02/18/2020
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 Health Professional
Device Model NumberMSERIES BI-PHASIC
Device Catalogue NumberM SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2020
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/18/2020
Initial Report FDA Received Date03/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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