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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 evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing which included bench handling, stress testing, power supply testing and battery testing without duplicating the malfunction.The battery used at the time of reported event was not returned for evaluation.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 a routine shift check by a clinician, the device inappropriately shut down.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 Key8651634
Report Number1220908-2019-01537
Device Sequence Number2129869
Product Code MKJ
UDI-Device Identifier00847946013424
UDI-Public00847946013424
Combination Product (Y/N)N
Initial Reporter StateFL
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) 05/16/2019
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 Manufacturer05/23/2019
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/16/2019
Initial Report FDA Received Date05/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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