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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER

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ZOLL MEDICAL CORPORATION R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number R SERIES
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/23/2019
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
 
Event Description
Complainant alleged that while attempting to pace a patient (age & gender unknown), after charging the machine to shock, the clinician received a small shock. Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
 
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, power cycling, stress testing, hipot test, leakage testing, internal inspection, and functionality testing without duplicating the customer report. The device was recertified and returned to the customer. There was no evidence in the activity log consistent with the customer report or to suggest the device malfunctioned. Analysis of reports of this type has not identified an increase in trend.
 
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Brand NameR SERIES DEFIBRILLATOR
Type of DeviceDEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key9043233
MDR Text Key158629562
Report Number1220908-2019-02675
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060559/P160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberR SERIES
Device Catalogue NumberR SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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