MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Codes	Failure to Charge (1085); Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and was unable to duplicate the reported issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio-control performed a clinical review of the reported patient event and concluded that the device use did not contribute to the outcome of the patient.This was determined by the review of the downloaded electronic event record showing the patient was in a non-shockable rhythm for the duration of the event.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted physio-control to report that they were using this device on a patient and the device did not recognize the defibrillation electrodes connected to the patient and would not charge defibrillation energy.They tried another set of defibrillation electrodes, but the device would still not charge.They switched to a back up device and were able to monitor the patient while performing cpr.The customer advised physio-control that the patient involved in the reported event is deceased.
Additional Manufacturer Narrative
Physio downloaded the device's electronic records from the event for review and determined that the likely cause of the reported issue was due to the user not selecting the paddles lead on the device.This resulted in the user not being able to view the patient's ecg through the defibrillation electrodes.
Event or Problem Description
The customer contacted physio-control to report that they were using this device on a patient and the device did not recognize the defibrillation electrodes connected to the patient and would not charge defibrillation energy.They tried another set of defibrillation electrodes, but the device would still not charge.They switched to a back up device and were able to monitor the patient while performing cpr.The customer advised physio-control that the patient involved in the reported event is deceased.

• Brand Name: LIFEPAK® 15 DEFIBRILLATOR/MONITOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 8786994
• Report Number: 0003015876-2019-01203
• Device Sequence Number: 14023546
• Product Code: MKJ
• UDI-Device Identifier: 00883873988114
• UDI-Public: 00883873988114
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• 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,Followup
• Report Date (Section B): 09/13/2019

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: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-000037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 09/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR