ZOLL CARDIAC MONITOR X-SERIES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-26 for ZOLL CARDIAC MONITOR X-SERIES manufactured by Zoll Medical Corporation.

MAUDE Entry Details

Report NumberMW5091333
MDR Report Key9384058
Date Received2019-11-26
Date of Report2019-11-25
Date of Event2019-11-21
Date Added to Maude2019-11-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameZOLL CARDIAC MONITOR
Generic NameMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
Product CodeDRT
Date Received2019-11-26
Model NumberX-SERIES
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerZOLL MEDICAL CORPORATION
Manufacturer AddressCHELMFORD MA 01824 US 01824


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-26

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