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U.S. Department of Health and Human Services

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

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ZOLL MEDICAL CORPORATION X SERIES DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number X SERIES
Device Problems Communication or Transmission Problem (2896); Unexpected Shutdown (4019)
Patient Problem No Information (3190)
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 treat a patient (age & gender unknown), the device inappropriately shut down. Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
 
Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device. This supplemental medwatch report is also correcting information submitted on the initial medwatch report. Please reference device code. Evaluation results; the customer's report was observed during initial testing. Our evaluation found that the data logging was out of sync when the device was trying to transmit and/or store data. This is commonly seen when there are frequent power cycles of short duration when the log is full. Regular clearing of the device history logs should prevent such occurrences. As a result of the findings, the logs have been fully cleared to resolve the report. This report was inadvertently submitted and reports of this nature typically do not meet zoll's reportability requirements. Analysis of reports of this type has not identified an increase in trend.
 
Event Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device had a case review transmission failure. Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
 
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Brand NameX SERIES
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 Key9433614
MDR Text Key169796050
Report Number1220908-2019-03773
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K112432/P160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberX SERIES
Device Catalogue NumberX SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2017
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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