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

Model Number	15
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Device Sensing Problem (2917)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that during a patient event their device was having a connection problem between the device and the defibrillation electrodes.The customer advised that the device lost contact with the patient.They also advised the device prompted "connect electrodes".In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.The patient did not survive.However the customer advised that the patient was in asystole upon arrival to the er and never regained rosc.
Additional Manufacturer Narrative
The customer provided stryker with all the available patient information.Patient fields in which information was not provided were intentionally left blank.Stryker performed a clinical review of the patient event and determined that the device use did not contribute to the patient outcome due to the patient was asystole upon arrival and never regained rosc.Stryker continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Event or Problem Description
The customer contacted stryker to report that during a patient event their device became stuck in aed mode.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.The patient did not survive.However the customer advised that the patient was in asystole upon arrival to the er and never regained rosc.
Additional Manufacturer Narrative
Section b5 of the initial medwatch report (mfr report #0003015876-2024-00131) indicates: executive summary: the customer contacted stryker to report that during a patient event their device was having a connection problem between the device and the defibrillation electrodes.The customer advised that the device lost contact with the patient.They also advised the device prompted "connect electrodes".In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.The patient did not survive.However, the customer advised that the patient was in asystole upon arrival to the er and never regained rosc.Section b5 of the initial medwatch report (mfr report #0003015876-2024-00131) should indicate: executive summary: the customer contacted stryker to report that during a patient event their device became stuck in aed mode.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.The patient did not survive.However, the customer advised that the patient was in asystole upon arrival to the er and never regained rosc.Additional information: stryker evaluated the customer's device and was unable to verify or 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 determined.

• 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
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18530891
• Report Number: 0003015876-2024-00131
• Device Sequence Number: 17830313
• Product Code: MKJ
• UDI-Device Identifier: 00883873853863
• UDI-Public: 00883873853863
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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: 99507-000122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White