X SERIES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for X SERIES manufactured by Zoll Medical Corporation.

Event Text Entries

[185795453] Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Patient Sequence No: 1, Text Type: N, H10


[185795494] Complainant alleged that while attempting to treat a female patient (age unknown), the device displayed "defib disabled"and "pacer disabled" messages. Complainant indicated that the clinician obtained another device to continue treating the patient. Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220908-2020-00823
MDR Report Key9905394
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-10
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2017-04-01
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street269 MILL ROAD
Manufacturer CityCHELMSFORD MA 01824
Manufacturer CountryUS
Manufacturer Postal01824
Manufacturer Phone9784219552
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameX SERIES
Generic NameDEFIBRILLATOR/PACEMAKER
Product CodeMKJ
Date Received2020-03-31
Model NumberX SERIES
Catalog NumberX SERIES
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZOLL MEDICAL CORPORATION
Manufacturer Address269 MILL ROAD CHELMSFORD MA 01824 US 01824


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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