AUTOPULSE? PLATFORM RESUSCITATION MODEL 100 8700-0730-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for AUTOPULSE? PLATFORM RESUSCITATION MODEL 100 8700-0730-01 manufactured by Zoll Circulation.

MAUDE Entry Details

Report Number3010617000-2020-00324
MDR Report Key9908288
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-02
Date Mfgr Received2020-03-06
Device Manufacturer Date2010-07-02
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 ContactMS. KIM THOA NGUYEN
Manufacturer Street2000 RINGWOOD AVE,
Manufacturer CitySAN JOSE, CA
Manufacturer CountryUS
Manufacturer Phone4192922
Manufacturer G1ZOLL CIRCULATION
Manufacturer Street2000 RINGWOOD AVE.
Manufacturer CitySAN JOSE, CA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAUTOPULSE? PLATFORM RESUSCITATION
Generic NameCARDIAC CHEST COMPRESSOR
Product CodeDRM
Date Received2020-03-31
Returned To Mfg2020-03-19
Model NumberMODEL 100
Catalog Number8700-0730-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerZOLL CIRCULATION
Manufacturer Address2000 RINGWOOD AVE. SAN JOSE, CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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