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

Model Number 20

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 12/16/2013

Event Type  malfunction  

Event Description

The customer, a biomed, contacted physio-control to report that the quik-combo therapy cable that was being used in conjunction with their device was not working properly.Further details were not provided regarding the exact issue being experienced.There was no patient use associated with the reported event.

Manufacturer Narrative

(b)(4).Physio-control assisted the customer with purchasing a replacement quik-combo therapy cable.Neither the cable, or the device, have been returned to physio-control for evaluation.The cause of the reported failure could not be determined.

Manufacturer Narrative

The initial medwatch report indicates: the customer, a biomed, contacted physio-control to report that the quik-combo therapy cable that was being used in conjunction with their device was not working properly.Further details were not provided regarding the exact issue being experienced.There was no patient use associated with the reported event.The initial medwatch report should indicate: the customer contacted physio-control to report that their device was not working and that a new therapy connector assembly was needed to resolve the reported issue for the unit.Further details were not provided regarding the exact issue being experienced.There was no patient use associated with the reported event.Catalog number of the initial medwatch report indicates: 3202459.Catalog number of the initial medwatch report should indicate: 3202488.The initial medwatch report indicates: physio-control assisted the customer with purchasing a replacement quik-combo therapy cable.Neither the cable, or the device, have been returned to physio-control for evaluation.The cause of the reported failure could not be determined.The initial medwatch report should indicate: physio-control assisted the customer with purchasing a replacement therapy connector assembly.After multiple attempts, physio-control has been unable to contact the customer for more information regarding the reported issue.The device has not been returned to physio-control for evaluation.The cause of the reported issue could not be determined.

• 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: 3572301
• MDR Text Key: 4079315
• Report Number: 3015876-2014-00032
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/16/2013

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: 3202488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 8 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/20/2014
• Initial Date FDA Received: 01/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2005
• 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