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

Model Number	15
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	09/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that during a patient event their device prompted, "attach pads".The customer advised that the patient was being paced.When they arrived at their destination, the reported message prompt was observed.It was noted at the time that the patient was in asystole.In this state, the device could delay or prohibit the delivering of defibrillation therapy to a patient if needed.This issue is patient related; however, there was no adverse patient outcome reported.
Additional Manufacturer Narrative
Stryker has reported all information available at this time.Patient and initial reporter fields in which information is not provided were intentionally left blank.Stryker evaluated the customer's device but was unable to verify or duplicate the reported issue.After observing proper device operation through functional and performance testing the unit was returned to the customer for use.The cause of the reported issue could not be determined.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18030333
• Report Number: 0003015876-2023-02005
• Device Sequence Number: 7017610
• Product Code: MKJ
• UDI-Device Identifier: 00883873905609
• UDI-Public: 00883873905609
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2023

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: 99577-001275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2015
• 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: Male