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

Model Number 15

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 08/04/2020

Event Type  Death  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Physio-control performed an initial evaluation of the customers device and verified the reported issue.Physio-control performed a clinical review of the available data and determined that the device use may have contributed to the patient's outcome.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer contacted physio-control to report that their device was used with patient ((b)(6)yoa male) in vfib, used fast patches only (no ecg) - attempted to deliver (2) shocks but both times the unit gave 'abnormal energy delivered' error.In this state the device may not be able to deliver appropriate defibrillation therapy if needed.The user indicated a back up device was use and that the patient did not survive the event.

Event Description

The customer contacted physio-control to report that their device was used with patient (56yoa male) in vfib, used fast patches only (no ecg) - attempted to deliver (2) shocks but both times the unit gave 'abnormal energy delivered' error.In this state the device may not be able to deliver appropriate defibrillation therapy if needed.The user indicated a back up device was use and that the patient did not survive the event.

Manufacturer Narrative

Physio-control received additional patient information from the customer.The customer provided physio-control with the available patient information.Patient fields in which information is not provided were intentionally left blank.

Event Description

The customer contacted physio-control to report that their device was used with patient (56 y o a male) in vfib, used fast patches only (no ecg) - attempted to deliver (2) shocks but both times the unit gave 'abnormal energy delivered' error.In this state the device may not be able to deliver appropriate defibrillation therapy if needed.The user indicated a back up device was use and that the patient did not survive the event.

Manufacturer Narrative

Physio updated the device's software to resolve the reported issue.Proper device operation was observed 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
• MDR Report Key: 10488679
• MDR Text Key: 205512403
• Report Number: 0003015876-2020-01177
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873988039
• UDI-Public: 00883873988039
• Combination Product (y/n): N
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-000045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR
• Patient Weight: 113