MAUDE Adverse Event Report: PHYSIO CONTROL INC. PHYSIO CONTROL; LIFEPAK15

Model Number LIFEPAK15

Device Problems Invalid Sensing (2293); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2017

Event Type  malfunction  

Event Description

The monitor was placed on a pt in cardiac arrest and the monitor initially showed asystole on the screen.During the arrest, the screen displayed continued asystole for the remainder of the arrest with no palpable pulse.Upon qa review, the electronic device recording did not match the rhythm on the visible screen.The electronic recording displayed intermittent pea with a rate up to 60 beats per minute.The pt was being treated per acls protocol.

• Brand Name: PHYSIO CONTROL
• Type of Device: LIFEPAK15
• Manufacturer (Section D): PHYSIO CONTROL INC.; redmond WA
• MDR Report Key: 6559835
• MDR Text Key: 75020876
• Report Number: MW5069681
• Device Sequence Number: 1
• Product Code: DRT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LIFEPAK15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: Yes
• 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): Other
• Patient Age: 39 YR
• Patient Weight: 64