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

Model Number 20

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 01/13/2014

Event Type  malfunction  

Event Description

It was reported that the therapy connector assembly on the customer's device had a broken connector pin stuck inside from the therapy cable assembly.A broken pin stuck within the therapy connector would prohibit the connection of another therapy cable assembly and would potentially prohibit defibrillation therapy delivery from the device.There was no patient use associated with the reported failure.

Manufacturer Narrative

(b)(4).Physio-control evaluated the device and verified the reported failure.Physio replaced the therapy connector assembly and observed proper device operation through functional and performance testing.The device was then 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: 3612649
• MDR Text Key: 4172883
• Report Number: 3015876-2014-00104
• 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: Other
• Type of Report: Initial
• Report Date: 01/13/2014

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: 01/13/2014
• Device Age: 9 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/13/2014
• Initial Date FDA Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2005
• 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