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

Model Number 20

Device Problem Failure to Charge (1085)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2014

Event Type  malfunction  

Event Description

The customer reported that the charge button on their device would not function.Without the functionality of this button, the device would not have the ability to charge defibrillation energy.There was no patient use associated with the reported failure.

Manufacturer Narrative

Physio-control evaluated the device and was unable to duplicate or verify the reported device issue.Proper device operation was observed through functional and performance testing and the device was then returned to the customer for use.The cause of the reported issue could not be determined.

• 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: 4334855
• MDR Text Key: 18894387
• Report Number: 3015876-2014-01504
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/19/2014

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: 3202487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 11 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2003
• 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