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 10/23/2014

Event Type  malfunction  

Event Description

It was reported that the customer's device would not complete a boot up cycle and had its service indicator illuminated.This was observed during testing and there was no patient use.

Manufacturer Narrative

(b)(4).Physio-control evaluated the device and verified the reported failure.Physio replaced the system controller and user interface pcb assemblies and observed proper device operation through functional and performance testing.The device was then returned to the customer for use.Physio further evaluated the removed pcb assemblies and determined that the cause of the reported failure was due to a failure of an integrated circuit chip, designator u61 from the system controller 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: 4265134
• MDR Text Key: 5295768
• Report Number: 3015876-2014-01391
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2014

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: 10/23/2014
• Device Age: 10 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/23/2014
• Initial Date FDA Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2004
• 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