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 Patient Involvement (2645)

Event Date 04/27/2015

Event Type  malfunction  

Event Description

The customer contacted physio-control to inquire about repairing their internal paddle defibrillation cable assembly.It was reported that the cable assembly was not consistently defibrillating when used with their device.There was no patient use associated with this event.

Manufacturer Narrative

(b)(4).Physio-control provided the customer with technical assistance.Physio advised the customer that the internal paddles are not field serviceable and recommended that they be replaced.Physio assisted the customer in ordering a replacement internal paddle assembly.The internal paddle assembly was not returned to physio for evaluation.The cause of the reported issue could not be determined.

• 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 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: 4785513
• MDR Text Key: 5805242
• Report Number: 3015876-2015-00570
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3010901
• Device Lot Number: 0603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/27/2015
• 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