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

Model Number 20

Device Problem Charging Problem (2892)

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

Event Date 08/01/2014

Event Type  malfunction  

Manufacturer Narrative

Physio-control evaluated the removed therapy pcb assembly, energy storage capacitor and the inductive resistor.Physio-control determined that the cause of the reported failure was due to a diode, designator cr44 on the therapy pcb assembly being shorted, which caused the device not to charge defibrillation energy.

Event Description

The customer reported to physio-control that their device did not charge to the desired energy level during reanimation of a patient.The charge was removed and a shock could not be delivered.During device evaluation it was observed that the device would not charge to the desired energy level, but would remove the charge.A defibrillation shock could therefore not be delivered.There was patient use associated with the reported event however, there was no adverse patient outcome reported.A backup device was used to treat the patient.

Manufacturer Narrative

(b)(4).A third-party service agent evaluated the device and verified the reported failure.The third-party service agent replaced the therapy pcb assembly, the energy storage capacitor and the inductive resistor.Proper device operation was observed through functional and performance testing.Following repair, the device was 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: 4053679
• MDR Text Key: 12420391
• Report Number: 3015876-2014-01031
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/08/2014

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?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 6 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/29/2014
• Initial Date FDA Received: 09/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2008
• 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
• Patient Age: 76 YR
• Patient Weight: 80