MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number 20

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2014

Event Type  malfunction  

Event Description

It was reported to physio-control that the customer's device would not boot up completely.After approximately 20 seconds, the device's display would turn completely white or black and the service wrench led would go on.There was patient use associated with the reported event; however, there was no negative outcome for the patient reported.

Manufacturer Narrative

A third-party service agent evaluated the device and verified the reported failure.The third-party service agent replaced the system controller pcb assembly and the user interface pcb assembly.Proper device operation was then observed through functional and performance testing.Following repair, the device was returned to the customer for use.

Manufacturer Narrative

Physio-control evaluated the removed user interface pcb assembly and system pcb assembly.Physio-control determined that the cause of the reported failure was due to an integrated circuit (ic) chip, designator u61 on the system pcb assembly.This integrated circuit (ic) chip, designator u61 on the system pcb assembly caused the device to reset and then lock-up.The device would not deliver defibrillation therapy.

• Brand Name: LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 970
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 970
• Manufacturer Contact: jason march ; 4258674000
• MDR Report Key: 4131147
• MDR Text Key: 15998683
• Report Number: 3015876-2014-01151
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• 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: 3202487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 11 YR
• Event Location: Hospital
• Date Manufacturer Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2003
• 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