HEART-SYNC ADULT RADIOLUCENT T-100 - PHILIPS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-26 for HEART-SYNC ADULT RADIOLUCENT T-100 - PHILIPS manufactured by Heart-sync.

Event Text Entries

[1726434] Unable to interconnect heart-sync t-100 brand defibrillator electrode to philips brand mrx defibrillator cable connector during preparation for pt care intervention. After various attempts by two clinicians present, the connector stopped 1/2" short from complete contact. After proper pt assessment utilizing a 5 lead cardiac monitor. It was determined defibrillation was not indicated due to a complete asystole arrythmia. Had the pt required electrical therapy, the connector malfunction would have prevented proper clinical intervention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5019186
MDR Report Key1976594
Date Received2011-01-26
Date of Report2011-01-26
Date Added to Maude2011-02-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHEART-SYNC
Generic NameDEFIBRILLATOR ELECTRODE
Product CodeDRK
Date Received2011-01-26
Model NumberADULT RADIOLUCENT
Catalog NumberT-100 - PHILIPS
Lot NumberY122909-22
Device Expiration Date2013-06-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerHEART-SYNC
Manufacturer Address5643 PLYMOUTH RD ANN ARBOR MI 48105 US 48105


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2011-01-26

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