MAUDE Adverse Event Report: PHYSIO-CONTROL, INC HANDLES AND CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Catalog Number 3010901

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control provided the customer with technical assistance.The customer advised that she was unsure how many sterilization cycles the internal paddles had been through during their lifetime.Physio-control advised the customer that the internal paddles were no longer under warranty.The customer advised that they have removed this set of internal paddles from service and will be obtaining a replacement set.Neither the lifepak 12 device nor the internal paddles have been returned to physio-control for evaluation.The cause of the reported issue could not be determined.

Event Description

The customer contacted physio-control to report that during a recent patient event they were unable to shock using a set of internal hard paddles in conjunction with their lifepak 12 device.The customer advised that they were able to charge to 20 joules but when they attempted to shock, the energy was dumped internally.This occurred three times.On the fourth attempt, the customer was able to successfully charge and shock.There were no adverse effects to the patient as a result of the reported issue.The patient survived the event.No further details about the patient or the event were provided.

• Brand Name: HANDLES AND CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION
• 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 9706
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 9706
• Manufacturer Contact: yuchol kim ; 4258674000
• MDR Report Key: 5478445
• MDR Text Key: 39640314
• Report Number: 3015876-2016-00244
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K895379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3010901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/09/2016
• 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