MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number 20

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 03/26/2014

Event Type  malfunction  

Event Description

The customer initially reported that their device had its service indicator illuminated and had logged some event codes.Upon evaluation of the device by physio-control, it was observed that the device was missing the positive portion of the biphasic defibrillation waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.There was no report of patient use associated with the reported issue.

Manufacturer Narrative

Physio-control evaluated the device and verified the reported failure.Physio replaced the therapy pcb assembly 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 therapy pcb assembly and determined that the cause of the reported failure was due to a cracked/open filter, designator fl29.

• 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: 4215915
• MDR Text Key: 5037986
• Report Number: 3015876-2014-01292
• 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
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• 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: 09/16/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 10 YR
• Event Location: Hospital
• Date Manufacturer Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2004
• 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