MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. LIFEPAK INTERNAL DEFIBRILLATOR CABLE/PADDLES; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Catalog Number 3006569

Device Problems Failure to Deliver Energy (1211); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 06/13/2014

Event Type  malfunction  

Event Description

Surgeon wanted the internal defibrillator paddles charged at 20 joules.The paddles were charged at 20 joules and they were not delivering a charge.We attempted charging the paddles and delivering the charge x 3 times, all unsuccessfully.The monitor had an error that read "abnormal energy delivered." we checked the cords and verified that everything was hooked up appropriately, but they still did not deliver the charge.I then opened up and passed a new pair of internal defibrillator paddles to the field, which then worked appropriately and delivered the charge.Following the end of the procedure, we tested the monitor and the test "succeeded.".

• Brand Name: LIFEPAK INTERNAL DEFIBRILLATOR CABLE/PADDLES
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): PHYSIO-CONTROL, INC.; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 4205781
• MDR Text Key: 4964211
• Report Number: 4205781
• Device Sequence Number: 1
• Product Code: LDD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 3006569
• Device Lot Number: 11 13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2014
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 78