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

Model Number 20

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 07/16/2014

Event Type  malfunction  

Event Description

It was reported by a physio-control service representative that a loaner device would continually reset during the boot-up sequence.This was observed during testing and there was no patient use associated.

Manufacturer Narrative

Physio-control evaluated the device and verified the reported failure.Physio replaced the flex cable assembly which connects the user interface pcb to the pcb stack and observed proper device operation through functional and performance testing.The device was then returned to the customer for use.The removed flex cable assembly was further evaluated in the failure analysis center.It was observed that the flex pads from flex cable connector, designator p21 were broken away from the solder at the pins.

• 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: 4001580
• MDR Text Key: 20973441
• Report Number: 3015876-2014-00925
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service and Testing Personnel
• Device Model Number: 20
• Device Catalogue Number: 3202488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2014
• Is the Reporter a Health Professional?: No
• Device Age: 12 YR
• Event Location: Other
• Date Manufacturer Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2002
• 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