MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION 9131 DEFIBRILLATION ELECTRODES

Model Number	9131
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	02/15/2017
Type of Reportable Event	Death
Event or Problem Description
The aed was used on a male subject who was entering the u.S.From (b)(6).When the cbp officer tried to adhere the defibrillation pads to the subject only one pad stayed attached to him.The adhesive wasn't on the other pad and was on the blue colored release liner.The users attempted to utilized another aed that was in close proximity, however, by that time the (b)(6) fire department was onsite and took over the rescue and transported the subject to a local hospital.The subject passed away in route to the hospital.
Additional Manufacturer Narrative
Examination of the pads found evidence that one of the pads was improperly removed from the blue release liner.Peeling a pad incorrectly from the liner may cause the gel to separate from the pad and remain attached to the liner.A pad with missing gel may not adhere to a patient.
Event or Problem Description
The aed was used on a male subject who was entering the u.S.From (b)(6).When the cbp officer tried to adhere the defibrillation pads to the subject only one pad stayed attached to him.The adhesive wasn't on the other pad and was on the blue colored release liner.The users attempted to utilized another aed that was in close proximity, however, by that time the (b)(6) fire department was onsite and took over the rescue and transported the subject to a local hospital.The subject passed away in route to the hospital.

• Brand Name: 9131 DEFIBRILLATION ELECTRODES
• Common Device Name: DEFIBRILLATION ELECTRODES
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; n7 w22025 johnson drive; waukesha WI 53186 1856
• MDR Report Key: 6396521
• Report Number: 2112020-2017-00002
• Device Sequence Number: 975301
• Product Code: MKJ
• UDI-Device Identifier: 00812394020102
• UDI-Public: (01)00812394020102(11)150917(17)180317(10)150701-02
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2017

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: Other
• Device Expiration Date: 03/17/2018
• Device Model Number: 9131
• Device Lot Number: 150701-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 03/24/2017
• 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: Death