MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. PHYSIO CONTROL; LIFEPAK 15

Device Problem Insufficient Information (3190)

Patient Problems Apnea (1720); Cardiac Arrest (1762); Ventricular Tachycardia (2132)

Event Date 11/03/2016

Event Type  Injury  

Event Description

Cardiac monitor was placed on a pt who was initially in sinus tachycardia.The pt shortly thereafter experienced ventricular tachycardia, cardiac arrest and was defibrillated.On the next rhythm check, the pt was found to be in asystole and remained in asystole from that point forward.Upon later review (inclusive of reviewing the pt's cardiac rhythm was recorded by the lifepak 15), it was noted the monitor was displaying a flat-line (asystole) on the visible screen while simultaneously recording an organized rhythm without pulses (pulseless electrical activity or pea) which was discovered by viewing the electronic code summary record.The pea was of varying rate corresponding to epinephrine administrations.At no time after the initial defibrillation did the visible screen on the monitor ever display an organized rhythm and the pt remained pulseless and apneic which clinically aligned with the visible screen's display of asystole.The monitor's screen display and the recording of the rhythm by the monitor internally did not correspond.The pt was being treated according to acls protocols and did not adversely affect this pt.It was discovered through routine quality review processes.

• Brand Name: PHYSIO CONTROL
• Type of Device: LIFEPAK 15
• Manufacturer (Section D): PHYSIO-CONTROL, INC.; redmond WA
• MDR Report Key: 6547384
• MDR Text Key: 74629434
• Report Number: MW5069585
• Device Sequence Number: 1
• Product Code: MKJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Weight: 48