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

Model Number 20

Device Problem Use of Device Problem (1670)

Patient Problem Ventricular Fibrillation (2130)

Event Date 12/04/2014

Event Type  Injury  

Event Description

The customer, a biomedical engineer, contacted physio-control to report that during a recent patient event, that they believed that the device provided a synchronized cardioversion defibrillator shock on the patient's t wave instead of the r wave.As a result of the shock, the patient's heart rhythm converted to ventricular fibrillation, a life threatening condition, which required medical intervention to correct.Medical personnel then provided one (1) additional asynchronous shock of 200 joules to the patient, 13 seconds after the initial shock, in order to correct the patient's heart rhythm.The patient, a male (age unknown), survived the event.No further details about the patient or the event were provided.

Manufacturer Narrative

(b)(4).A copy of the code summary printout was sent to physio-control for a clinical analysis.A review of the reported event was conducted by a clinical specialist who concluded that the cause of the reported issue was use error.It was observed in the code summary printout that the device user failed to turn on the defibrillator's sync function prior to administering the defibrillator shock to the patient and, as a result, shocked the patient on the t wave which caused the patient's ecg rhythm to convert to ventricular fibrillation.There was no failure of the device.Physio-control contacted the customer to advise them of the investigation results.The customer advised physio that they too had believed that the reported issue was the result of use error, but wanted a second opinion.Physio offered to provide additional product training but the customer declined, advising that additional training had already been completed by the hospital staff.The device has not been 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: 4372429
• MDR Text Key: 5284150
• Report Number: 3015876-2014-01587
• 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: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 8 YR
• Event Location: Hospital
• Date Manufacturer Received: 12/04/2014
• Date Device Manufactured: 04/27/2006
• 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
• Patient Outcome(s): Life Threatening; Required Intervention