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 09/04/2014

Event Type  malfunction  

Event Description

The customer contacted physio-control to report that their device required servicing.There was no patient use associated with the reported event.Upon evaluation of the device, physio-control observed the device reset itself, or locked up when powered on.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.

Manufacturer Narrative

(b)(4).Physio-control evaluated the customer¿s device and verified the reported failure.Physio-control replaced the power supply assembly.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 power supply assembly and it was observed that the cause of the reported failure was due to process residue contamination on a filter, designator fl4, from the power pcb assembly.The power pcb assembly is a component located on the power supply 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: 4173638
• MDR Text Key: 18795660
• Report Number: 3015876-2014-01217
• 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: 09/19/2014

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: 3202488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2014
• Device Age: 8 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/19/2014
• Initial Date FDA Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2006
• 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