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Adverse Event Report

CARDIAC SCIENCE, INC. POWERHEART CRM CARDIAC RHYTHM MODULE (CRM)   back to search results
Model Number 180-2000
Event Date 06/19/2003
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Patient shocked in manual mode.

 
Manufacturer Narrative

There is a warning label on the top of the crm that states "caution: hazardous electrical output. This device is for use only by qualified personnel".

 
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Brand NamePOWERHEART CRM
Type of DeviceCARDIAC RHYTHM MODULE (CRM)
Baseline Brand NamePOWERHEART
Baseline Generic NameCARDIAC RHYTHM MODULE (CRM)
Baseline Catalogue NumberNA
Baseline Model Number180-2000
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CARDIAC SCIENCE, INC.
5474 feltl rd.
minnetonka MN 55343
Manufacturer (Section D)
CARDIAC SCIENCE, INC.
5474 feltl rd.
minnetonka MN 55343
Manufacturer Contact
virginia pease
5474 feltl road
minnetonka , MN 55343
(952) 939 -2923
Device Event Key464249
MDR Report Key475400
Event Key450594
Report Number2132572-2003-00019
Device Sequence Number1
Product CodeMKJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation UNKNOWN
Remedial Action Notification
Type of Report Initial
Report Date 07/09/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/25/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL Number180-2000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Unknown
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2002
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on February 28, 2009

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