MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION INTELLISENSE BATTERY POWERHEART G5; AED BATTERY

Model Number	XBTAED001A
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cardiac science is attempting to contact the person who was shocked in order to obtain additional information about the event.
Event or Problem 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 or Problem 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.
Additional 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.

• Brand Name: INTELLISENSE BATTERY POWERHEART G5
• Common Device Name: AED BATTERY
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield, wi WI 53531 9692
• MDR Report Key: 9244728
• Report Number: 2112020-2019-00022
• Device Sequence Number: 3660695
• Product Code: MKJ
• UDI-Device Identifier: 00812394020904
• UDI-Public: 00812394020904
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: XBTAED001A
• Device Catalogue Number: XBTAED001A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization