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 01/30/2014

Event Type  malfunction  

Event Description

Physio-control examined the customer's device and observed that the unit would not charge, in order to defibrillate, when prompted.There was no patient use associated with the reported event.

Manufacturer Narrative

(b)(4).Physio-control examined the customers device and verified the reported failure.Physio replaced the therapy pcb assembly, energy storage capacitor and inductive resistor assembly.After observing proper device operation through functional and performance testing the device was returned to the customer for use.Physio further evaluated the removed therapy pcb assembly and determined that the cause of the reported failure was two shorted diodes, designators cr22 and cr23.It was also observed that the energy storage capacitor measured at 192uf, when it should be at/above 196uf; however, it did not contribute to the reported failure.The removed inductive resistor assembly tested ok.

• 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: 3651188
• MDR Text Key: 4287322
• Report Number: 3015876-2014-00189
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 20
• Device Catalogue Number: 3202488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2014
• Device Age: 7 YR
• Event Location: Other
• Date Manufacturer Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2006
• 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