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 06/17/2014

Event Type  malfunction  

Manufacturer Narrative

Physio-control 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.

Manufacturer Narrative

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.

Event Description

The customer contacted physio-control to report that their device would intermittently reboot itself and not complete the boot up cycle.In this state the device would be inoperable and defibrillation therapy would not be available if needed there was no patient use associated with the reported event.

Manufacturer Narrative

(b)(4): physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

• 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: 3938218
• MDR Text Key: 12178876
• Report Number: 3015876-2014-00809
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2014

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: 08/09/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 10 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/08/2014
• Initial Date FDA Received: 07/16/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/28/2014; 09/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2004
• 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