CONFIRM DM3500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for CONFIRM DM3500 manufactured by Abbott.

Event Text Entries

[185931884] The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10


[185931885] During follow-up, the diagnostic information from the egms was missing. Technical support recommended sending screenshots of the session records. No intervention was performed to resolve the event and the patient was stable. Further information was requested but not received.
Patient Sequence No: 1, Text Type: D, B5


[186482066] Additional information: upon review, this product should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused by the device.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2017865-2020-04491
MDR Report Key9908147
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-04-01
Date of Event2020-03-16
Date Mfgr Received2020-04-01
Device Manufacturer Date2018-07-02
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 ContactELIZABETH BOLTZ
Manufacturer Street15900 VALLEY VIEW COURT
Manufacturer CitySYLMAR CA 91342
Manufacturer CountryUS
Manufacturer Postal91342
Manufacturer G1ABBOTT
Manufacturer Street15900 VALLEY VIEW COURT
Manufacturer CitySYLMAR CA 91342
Manufacturer CountryUS
Manufacturer Postal Code91342
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONFIRM
Generic NameIMPLANTABLE CARDIAC MONITOR
Product CodeMXC
Date Received2020-03-31
Model NumberDM3500
Catalog NumberDM3500
Lot NumberS000062430
Device Expiration Date2019-12-25
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT
Manufacturer Address15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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