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

Model Number 15

Device Problems Defibrillation/Stimulation Problem (1573); Device Sensing Problem (2917)

Patient Problem Asystole (4442)

Event Date 08/30/2023

Event Type  malfunction  

Event 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.

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 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.

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
• Type of Device: 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
• MDR Text Key: 333245538
• Report Number: 0003015876-2024-00131
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873853863
• UDI-Public: 00883873853863
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White