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

Model Number 15

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Death (1802)

Event Date 09/09/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).Physio-control reviewed the electronic patient record of the reported event.The shock advisory system renders a shock or no shock decision based upon analysis of a 3 rhythm segment voting scheme.During segment 1, of analysis 1, the patient was in an organized rhythm that resulted in a no shock vote.During segments 2 and 3, it appears that chest compressions were being performed, affecting the algorithmic interpretation of the rhythm.The cause of the reported issue was determined to be due to use error.The user failed to hold chest compressions during aed rhythm analysis in segments 2 and 3, and was therefore not following the operating instructions that state to stop cpr after the analyze button is pressed.Device not evaluated by manufacturer.

Event Description

The customer contacted physio-control to report that their device had advised a shock, in aed mode, for a rhythm that was believed to be non- shockable.

• 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 9182083
• MDR Text Key: 162050894
• Report Number: 0003015876-2019-01683
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/11/2016
• 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 Outcome(s): Death
• Patient Age: 89 YR