MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION 9131 DEFIBRILLATION ELECTRODES

Model Number	9131
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer didn't keep the pads used in the rescue; however, they did keep the pouch which lists the manufacturing date, lot number, and expiration date.Review of complaint records found no other reported problems associated with the lot of pads used in the rescue.Technical and clinical reviews of the rescue data downloaded from the aed were performed and determined the aed functioned correctly in the rescue.The user had pressed the pad onto the adhesive (gel) and the contact between the pad and patient was good enough to allow the aed to detect that pads were attached to the patient.The aed analyzed the patient's rhythm, categorized the rhythm as nonshockable, advised no shock, and then prompted for cpr.Since the pads used in the rescue weren't available for examination, the root cause of the gel coming off the pads is unknown.The cause of the reported problem may have been improper handling of the pads prior to use.
Event or Problem Description
The nurse was called to evaluate the condition of a resident who was unresponsive and had ashen skin color.Resident was put to bed and was determined to have apnea and no carotid pulse.Cpr was initiated and the aed was applied.When the pads were removed from the packaging the adhesive on the pads stuck together and had to be peeled apart.The adhesive was applied to the resident's skin and the pad was placed on top of adhesive and pressed onto the adhesive.After analyzing the resident the aed prompted the user to continue cpr.The ems arrived, switched the aed with their own, administered iv meds, and shocked the patient with their aed.The resident was transported to the hospital with cpr still in progress.Customer reported that the patient had expired.

• Brand Name: 9131 DEFIBRILLATION ELECTRODES
• Common Device Name: DEFIBRILLATION ELECTRODES
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• MDR Report Key: 7401624
• Report Number: 2112020-2018-00008
• Device Sequence Number: 13807239
• Product Code: MKJ
• UDI-Device Identifier: 00812394020102
• UDI-Public: 00812394020102
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K102496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 05/28/2019
• Device Model Number: 9131
• Device Lot Number: 161110-05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 04/05/2018
• 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