MAUDE Adverse Event Report: PHYSIO CONTROL PHYSIO CONTROL; LIFEPAK 15 MONITOR/DEFIBRILLATOR

Model Number LIFEPAK 15

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Cardiac Arrest (1762)

Event Date 02/06/2017

Event Type  Death  

Event Description

Ems finds the patient unresponsive, with a pulse and agonal respirations.They attached the cardiac monitor to the patient through a set of combo pads and obtained an ecg bradycardiac rhythm tracing displayed on the monitor screen.After a little less than 2 min, the monitor quit displaying the rhythm.It instead displayed only dashed lines.The crew changed to a new set of combo pads but where still unable to get a rhythm displayed on the monitor screen.At around this time the patient lost pulse and respirations completely and cpr was initiated by the crew.The crew switched to yet a 3rd new set of pads and upon attaching this 3rd set to the patient, they were able to get a rhythm displayed.Resuscitation measures were continued by ems enroute to the local emergency room with the patient remaining in cardiac arrest upon arrival there.

• Brand Name: PHYSIO CONTROL
• Type of Device: LIFEPAK 15 MONITOR/DEFIBRILLATOR
• Manufacturer (Section D): PHYSIO CONTROL; redmond WA
• MDR Report Key: 6347638
• MDR Text Key: 67960626
• Report Number: 6347638
• Device Sequence Number: 1
• Product Code: MKJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LIFEPAK 15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/06/2017
• Device Age: 18 MO
• Event Location: Other
• Date Report to Manufacturer: 02/07/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT RETRIEVABLE, FOR EVALUATION.; PHYSIO CONTROL BRAND QUIK COMBO PADS, 2 SETS,; THESE WERE THROWN AWAY AFTER THE CALL AND, ; UNK LOT #S, CAT# 11996-000091.
• Patient Outcome(s): Death
• Patient Age: 55 YR
• Patient Weight: 91