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 Run On AC/DC (1001)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/23/2014

Event Type  malfunction  

Event Description

The customer reported that during a patient event, their device did not deliver defibrillation energy.The customer stated that their patient coded and this device was initially able to successfully deliver defibrillation energy to the patient multiple times.The patient was then transferred to the ct lab and later, the patient coded again.During this code, the device lost power during the defibrillation charge cycle.Once this device lost power, the staff was able to deploy a back up device immediately and provided additional therapy to the patient.The patient survived the event and did not suffer any adverse effects as a result of the reported failure.

Manufacturer Narrative

(b)(4).The customer advised physio-control that they have evaluated the device and has been unable to duplicate or verify the reported failure.Proper device operation was observed through functional and performance testing and the device has been returned to the customer for use.The device has not been returned to physio-control for evaluation.The cause of the reported failure 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: 3941167
• MDR Text Key: 18573968
• Report Number: 3015876-2014-00819
• 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: 06/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• 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: 3202488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 6 YR
• Event Location: Hospital
• Date Manufacturer Received: 06/23/2014
• Date Device Manufactured: 11/01/2008
• 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