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

Model Number 15

Device Problem Failure to Sense (1559)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2023

Event Type  malfunction  

Event Description

The customer contacted stryker to report that their device failed to sense shockable rhythm 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.The health care provider confirmed that the device use did not contribute to the patient outcome.

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.   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.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 17760641
• MDR Text Key: 324081844
• Report Number: 0003015876-2023-01669
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873871690
• UDI-Public: 00883873871690
• 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
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• 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: 99577-001957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Date Manufacturer Received: 08/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 100 KG