MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES); DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Catalog Number	11131-000045
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report delay in the delivery of the shock during intervention on a patient.In this state the device may not be able to provide defibrillation therapy if it were needed.The patient associated with the reported event did not survive.
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.Stryker requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Stryker performed clinical review of the reported event and based on the current information present, it is unknown if the device use contributed to the patient outcome.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.
Additional Manufacturer Narrative
A stryker service representative performed an initial evaluation of the customer¿s device and was not able to duplicate the reported issue.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.New clinical review was performed since the device electronic records were available for review.The keylogs and pco files indicated that a total of 9 shocks were delivered during the reported event.The longest delay between shock button press and delivery of defibrillation energy was 6 seconds.As such, the reported issue was verified.It was determined that the device was in sync mode at the time of the reported event.The lp15 operating instructions (oi) states that when in sync mode the user must press and hold the shock button on the defibrillator until the energy delivered message appears.The device keylogs showed repetitive shock button presses rather than the shock button being pressed and held as instructed in the oi.The root cause of the reported issue was determined to be due to user error.The clinical review concluded that the device did not contribute to the reported adverse event.
Event or Problem Description
The customer contacted stryker to report delay in the delivery of the shock during intervention on a patient.In this state the device may not be able to provide defibrillation therapy if it were needed.The patient associated with the reported event did not survive.

• Brand Name: LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)
• Common Device Name: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• 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: 21060343
• Report Number: 0003015876-2025-00008
• Device Sequence Number: 21028226
• Product Code: LDD
• UDI-Device Identifier: 00883873863497
• UDI-Public: 00883873863497
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K960329
• 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): 05/14/2025

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 Catalogue Number: 11131-000045
• Device Lot Number: 011978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIFEPAK(R)15 MONITOR/DEFIBRILLATOR,MKJ,(B)(6)
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown