MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G3 AED DEFIBRILLATION PADS; DEFIBRILLATION ELECTRODES

Model Number	9131-001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The distributor has the pads used during the event in their possession and will send them to cardiac science for evaluation.The customer found additional pads from the same lot and these will be sent to the distributor who will forward them to cardiac science.
Event or Problem Description
A distributor notified cardiac science of an incident they received from an ambulance service in (b)(6).Cpr was started on the patient by the family.The ambulance service arrived at the scene and when the paramedic started opening the pads prior to placement on the patient, the paramedic noticed the gel was separating from the pads.The ambulance service used another set of pads to treat the patient.The patient did not survive.
Additional Manufacturer Narrative
The pads the paramedic had started to open during the rescue event were received along with 6 sets of unopened pads from the same lot.When the customer reported the event they provided a picture of the pad they attempted to use which showed the gel had folded over onto itself and become detached from the edge of the electrode.The second pad, which had not been removed from the release liner during the rescue, was peeled from the liner as part of cardiac science's evaluation.The pad peeled away from the liner without problems and the gel did not pull away from the electrode.The foam backing material of the pad with the detached gel was stretched which indicated the pad had likely been peeled from the release liner incorrectly.If pads are not peeled from the release liner as directed by the labeling they can be damaged and the gel may detach from the electrode.This is the only reported problem for pads from lot 190812-08.Seven (7) sets of replacement pads were sent to the customer.
Event or Problem Description
A distributor notified cardiac science of an incident they received from an ambulance service in sweden.Cpr was started on the patient by the family.The ambulance service arrived at the scene and when the paramedic started opening the pads prior to placement on the patient, the paramedic noticed the gel was separating from the pads.The ambulance service used another set of pads to treat the patient.The patient did not survive.

• Brand Name: POWERHEART G3 AED DEFIBRILLATION PADS
• Common Device Name: DEFIBRILLATION ELECTRODES
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield, wi WI 53531 9692
• MDR Report Key: 9501362
• Report Number: 2112020-2019-00026
• Device Sequence Number: 13922853
• Product Code: MKJ
• UDI-Device Identifier: 00812394020911
• UDI-Public: 00812394020911
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P160033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• 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: Other
• Device Expiration Date: 10/28/2021
• Device Model Number: 9131-001
• Device Catalogue Number: 9131-001
• Device Lot Number: 190412-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 12/20/2019
• 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: Death