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

Model Number 20

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 01/20/2014

Event Type  malfunction  

Event Description

The customer reported that a pin from the defibrillation therapy cable broke off into the therapy connector of the device.With this reported issue, the device could not have a different therapy cable or possibly the hard paddles assembly be connected for defibrillation and the device may not have the ability to deliver defibrillation therapy.There was no report of any patient use associated with the reported failure.

Manufacturer Narrative

(b)(4): physio-control provided the customer with the part number to replace the therapy connector assembly.The customer stated that they have disposed of the therapy cable assembly which this pin broke off of.Once the customer replaces the therapy connector assembly and after proper device operation is observed through functional and performance testing, the device will be returned to the end user for use.The device was not returned to physio-control for evaluation.

• 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: 3626361
• MDR Text Key: 4174641
• Report Number: 3015876-2014-00130
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2014
• 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: 3202487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 10 YR
• Event Location: Hospital
• Date Manufacturer Received: 01/20/2014
• Date Device Manufactured: 08/20/2004
• 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