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 08/08/2014

Event Type  malfunction  

Event Description

The customer contacted physio-control to report that their device would reboot itself during the user test.It was also reported that the service indicator was illuminated.There was no patient use associated with the reported event.Upon evaluation of the device, physio-control observed that the device locked up when powering on.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.

Manufacturer Narrative

Physio-control evaluated the customer¿s device and verified the reported failure.Physio-control replaced the system controller and user interface pcb assemblies.Thereafter proper device operation was observed through functional and performance testing and the device was returned to the customer for use.Physio-control further evaluated the removed system controller pcb assembly.It was determined that the cause of the reported issue was a failure of integrated circuit chip, designator u61.The removed user interface pcb assembly was an ancillary part and there was no failure of this 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: 4204210
• MDR Text Key: 17592735
• Report Number: 3015876-2014-01269
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 10 YR
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2004
• 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