ZOLL ECG ELECTRODES 8900-0005

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-29 for ZOLL ECG ELECTRODES 8900-0005 manufactured by Zoll Medical Corporation.

MAUDE Entry Details

Report Number9391743
MDR Report Key9391743
Date Received2019-11-29
Date of Report2019-11-22
Date of Event2019-11-18
Report Date2019-11-22
Date Reported to FDA2019-11-22
Date Reported to Mfgr2019-11-29
Date Added to Maude2019-11-29
Event Key0
Report Source CodeUser Facility 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 Report3

Device Details

Brand NameZOLL ECG ELECTRODES
Generic NameELECTRODE, ELECTROCARDIOGRAPH
Product CodeDRX
Date Received2019-11-29
Model Number8900-0005
Catalog Number8900-0005
Lot Number199458
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerZOLL MEDICAL CORPORATION
Manufacturer Address269 MILL ROAD CHELMSFORD MA 01824 US 01824


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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