KING OF HEARTS EXPRESS AF DEV056 LR075

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-03-04 for KING OF HEARTS EXPRESS AF DEV056 LR075 manufactured by Lifewatch Services, Inc..

Event Text Entries

[1480762] The pt called in to the acd line and stated that she received a shock to the heart from the electrodes and that she wanted to be compensated without getting a lawyer involved.
Patient Sequence No: 1, Text Type: D, B5


[8595671] Additional associated devices: monitor. Serial # (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3027765-2010-00005
MDR Report Key1633681
Report Source04
Date Received2010-03-04
Date of Report2009-11-18
Date of Event2009-11-18
Date Mfgr Received2009-11-18
Date Added to Maude2011-03-16
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 FDA0
Event Location0
Manufacturer ContactMARIKAY MENARD
Manufacturer StreetO'HARE INTERNATIONAL CENTER II 10255 WEST HIGGINS RD, STE 110
Manufacturer CityROSEMONT IL 60018
Manufacturer CountryUS
Manufacturer Postal60018
Manufacturer Phone8478132977
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKING OF HEARTS EXPRESS AF
Generic NameRECORDER, MAGNETIC TAPE, MEDICAL
Product CodeDXH
Date Received2010-03-04
Model NumberDEV056
Catalog NumberLR075
Lot NumberNA
ID NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLIFEWATCH SERVICES, INC.
Manufacturer AddressROSEMONT IL US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2010-03-04

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