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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION INTELLISENSE BATTERY POWERHEART G5; AED BATTERY
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CARDIAC SCIENCE CORPORATION INTELLISENSE BATTERY POWERHEART G5; AED BATTERY Back to Search Results
Model Number XBTAED001A
Device Problem Unintended Electrical Shock (4018)
Patient Problem Complaint, Ill-Defined (2331)
Event Type  malfunction  
Manufacturer Narrative
Cardiac science is attempting to contact the person who was shocked in order to obtain additional information about the event.
 
Event Description
The distributor reported they were contacted by a customer who reported to them that when one of their site nurses was installing a battery in an aed she had her finger across the metal conduction notches of the battery and it shocked her.The nurse was reported to be fine, but did feel "off" so the school called ems and she was transported to the hospital to be checked out, especially since she was pregnant.
 
Event Description
The distributor reported they were contacted by a customer who reported to them that when one of their site nurses was installing a battery in an aed she had her finger across the metal conduction notches of the battery and it shocked her.The nurse was reported to be fine, but did feel "off" so the school called ems and she was transported to the hospital to be checked out, especially since she was pregnant.
 
Manufacturer Narrative
After multiple follow-up attempts cardiac science has been unable to obtain additional information about the reported event.Based upon the design of the battery, it is currently unknown how the event occurred.No similar events have been previously reported to cardiac science.
 
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Brand Name
INTELLISENSE BATTERY POWERHEART G5
Type of Device
AED BATTERY
Manufacturer (Section D)
CARDIAC SCIENCE CORPORATION
500 burdick parkway
deerfield, wi WI 53531 9692
MDR Report Key9244728
MDR Text Key186743123
Report Number2112020-2019-00022
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00812394020904
UDI-Public00812394020904
Combination Product (y/n)N
PMA/PMN Number
P160033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberXBTAED001A
Device Catalogue NumberXBTAED001A
Was Device Available for Evaluation? No
Date Manufacturer Received06/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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