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 Patient Involvement (2645)

Event Date 11/13/2014

Event Type  malfunction  

Event Description

The customer contacted physio-control that the service led on their device was on.During device evaluation by physio-control it was observed that the device would not complete its boot cycle and kept rebooting.There was no patient use associated with the reported event.

Manufacturer Narrative

(b)(4): physio-control evaluated the device and verified the reported failure.It was observed that the device kept rebooting and would not complete its boot cycle.Physio-control replaced the user interface pcb assembly and system 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 and system pcb assemblies and determined that the cause of the reported issue was due to excessive electrical leakage of an integrated circuit (ic) chip, designator u61 on the system pcb assembly.This excessive electrical leagakge of integrated circuit (ic) chip, designator u61 caused an intermittent lock-up of the device during boot-up.No discrepancies were observed on the user interface pcb assembly.

• 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: 4349586
• MDR Text Key: 5173083
• Report Number: 3015876-2014-01534
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 10 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2004
• 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