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

Model Number 20

Device Problems Failure to Charge (1085); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/07/2014

Event Type  malfunction  

Event Description

The customer contacted physio-control to report that their device was displaying the service indicator.There was no patient use associated with the reported event.Upon evaluation of the device, physio-control observed that the device would not charge beyond 2 joules when prompted.Additionally physio observed that the device had logged event code 9c19.The event code is indicative of a device failure that could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.

Manufacturer Narrative

(b)(4).Physio-control evaluated the device and confirmed the reported issue.The cause of the reported issue was determined to be due to a failure of diode cr30 on the therapy pcb assembly.The diode was shorted from legs 5 and 8 to leg 9.The device was repaired by replacing the therapy pcb assembly.Following the repair, proper operation was confirmed during functional and performance testing.The device was subsequently returned to the customer for use.

• 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: 3875583
• MDR Text Key: 4565075
• Report Number: 3015876-2014-00662
• 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: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2014
• 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: 05/15/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 8 YR
• Event Location: Hospital
• Date Manufacturer Received: 05/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2005
• 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