LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR 99507-000107

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-03-31 for LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR 99507-000107 manufactured by Physio-control, Inc. - 3015876.

MAUDE Entry Details

Report Number0003015876-2020-00462
MDR Report Key9902099
Report SourceFOREIGN
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-03
Date Mfgr Received2020-03-03
Device Manufacturer Date2019-10-29
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
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. TODD BANDY
Manufacturer Street11811 WILLOWS ROAD NE
Manufacturer CityREDMOND WA 98052
Manufacturer CountryUS
Manufacturer Postal98052
Manufacturer Phone4258674000
Manufacturer G1PHYSIO-CONTROL, INC. - 3015876
Manufacturer Street11811 WILLOWS ROAD NE
Manufacturer CityREDMOND WA 98052
Manufacturer CountryUS
Manufacturer Postal Code98052
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIFEPAK(R) 20E DEFIBRILLATOR/MONITOR
Generic NameAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Product CodeMKJ
Date Received2020-03-31
Returned To Mfg2020-03-18
Model Number20E
Catalog Number99507-000107
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPHYSIO-CONTROL, INC. - 3015876
Manufacturer Address11811 WILLOWS ROAD NE REDMOND WA 98052 US 98052


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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