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

Model Number 15

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Ventricular Fibrillation (2130)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

Physio-control evaluated the customer¿s device and verified the reported issue.Physio replaced the device¿s main keypad assembly.After completing other unrelated repairs, proper device operation through functional and performance testing, the device was returned to the customer for use.Based on the information available, physio-control has determined that the likely cause of the reported issue was that the shock switch located on the main keypad assembly was out of tolerance due to excessive resistance. when this issue occurs, an event code will be logged in the device's memory following a failure of the device to deliver defibrillation energy.

Event Description

The customer contacted physio-control to report that their device failed to shock during code and illuminated the service light.This issue is patient related; however there was no adverse event reported.Upon evaluation of the customer's device, physio-control observed an event code logged in the device's memory.The event code logged is related to a potential failure of the device to deliver defibrillation energy.

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 failed to shock during code and illuminated the service light.This issue is patient related; however there was no adverse event reported.Upon evaluation of the customer's device, physio-control observed an event code logged in the device's memory.The event code logged is related to a potential failure of the device to deliver defibrillation energy.

• 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: 11258744
• MDR Text Key: 229628866
• Report Number: 0003015876-2021-00187
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873988022
• UDI-Public: 00883873988022
• Combination Product (y/n): N
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• 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: 99577-000046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3015876-11/18/2019-001C
• Patient Sequence Number: 1
• Patient Age: 65 YR