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

Model Number 15

Device Problems Failure to Deliver Shock/Stimulation (1133); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Patient Involvement (2645)

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio replaced the therapy pcb assembly.After observing proper device operation through functional and performance testing the device was returned to the customer for use.

Event Description

The customer contacted physio-control to report that their device service indicator was illuminated.There was no patient use associated with this event.Upon evaluation of the customer's device physio-control observed that the device had logged an event code in the memory which is related to a potential issue of the device to deliver defibrillation energy.Physio-control also observed that the device was unable to deliver over 200j of 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
• 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: 8740199
• MDR Text Key: 149378079
• Report Number: 0003015876-2019-01114
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873912775
• UDI-Public: 00883873912775
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• 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: 99577-001219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Date Manufacturer Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2012
• 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