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

Model Number	15
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Death (1802)
Date of Event	10/23/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and was unable to duplicate the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The cause of the reported issue could not be determine.Physio-control performed a clinical review of the event and concluded that the device use could have contributed to the patient's outcome.Physio-control reviewed the electronic patient record from the event and determined that defibrillation was needed, but the provision of defibrillation was delayed by more than 30 seconds.
Event or Problem Description
The customer contacted physio-control to report that they were using this device on a patient and had an issue with the aed function of the device.The device returned a "no shock advised" message to the user two to three times before advising the user to shock the patient.The user delivered a shock to the patient and then the device went back to the "no shock advised" message.The customer is unsure if the device returned the correct shock advisory messages during the event.The patient involved in this event, an (b)(6) male, is deceased.No further patient information was provided.
Additional Manufacturer Narrative
A physio-control research scientist evaluated the electronic patient record from the event and determined that the "no shock advised" decisions made by the device during the first three rhythm analyses were due to the presence of steep negative slopes in the ecg rhythm.The results were not indicative of a deviation from the established sensitivity and specificity of the lifepak shock advisory algorithm.No device malfunction was observed during the analysis of the electronic patient record.
Event or Problem Description
The customer contacted physio-control to report that they were using this device on a patient and had an issue with the aed function of the device.The device returned a "no shock advised" message to the user two to three times before advising the user to shock the patient.The user delivered a shock to the patient and then the device went back to the "no shock advised" message.The customer is unsure if the device returned the correct shock advisory messages during the event.The patient involved in this event, an (b)(6) male, is deceased.No further patient information was provided.

• 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: 8121247
• Report Number: 0003015876-2018-02022
• Device Sequence Number: 202526
• Product Code: MKJ
• UDI-Device Identifier: 00883873911679
• UDI-Public: 00883873911679
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2019

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: 15
• Device Catalogue Number: 99577-001252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 01/07/2019
• 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
• Patient Age: 86 YR