MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 20E

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio replaced the device's system controller pcb assembly and user interface pcb assembly to resolve the reported issue.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio-control further evaluated the removed user interface and system controller pcb assemblies.The cause of the reported issue was determined to be the user interface pcb assembly.A further component cause could not be determined.No issue was observed with the system controller pcb assembly.

Event Description

The customer contacted physio-control to report that their device was displaying a service indicator and has event codes logged in its memory.There was patient use associated with this event, but there were no reports of adverse effects to the patient as a result of the reported issue.Upon evaluation of the customer's device, physio-control observed that the device was intermittently booting up with a white display and when this occurred none of the keypad buttons were functioning.As a result, defibrillation therapy would not be available, if it was needed.

• Brand Name: LIFEPAK® 20E 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: megan marseglia ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 7539285
• MDR Text Key: 109109062
• Report Number: 0003015876-2018-00825
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20E
• Device Catalogue Number: 99507-000002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2011
• 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