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

Model Number 20

Device Problems Failure to Sense (1559); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned to physio-control.A third party service agent evaluated the customer's device and was unable to duplicate the customer's reported issue.Upon inspection, it was observed that the device delivered a monophonic energy instead of a biphasic energy.The service agent recommended replacing the therapy pcb assembly however the customer rejected the repair.The device was subsequently returned to the customer for use.Further investigation of the part is not possible.A root cause of the reported issue could not be determined.Device not evaluated by manufacturer.

Event Description

A customer contacted our third-party service agent to report that their device illuminated its service led and would not recognize the hard paddles when connected.In this state defibrillation therapy would not be able to be delivered.Upon initial evaluation, by the service agent, it was observed that the device logged an event code in its memory that resulted in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.There were no reports of patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 20 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: 8824482
• MDR Text Key: 152797938
• Report Number: 0003015876-2019-01261
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K130454
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20
• Device Catalogue Number: 99402-000071
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/17/2009
• 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