MAUDE Adverse Event Report: GENERAL ELECTRIC GENERAL ELECTRIC TELE AND B450; MONITOR, PHYSIOLOGICAL PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number B450

Device Problem Patient Data Problem (3197)

Patient Problem No Code Available (3191)

Event Date 12/09/2019

Event Type  Injury  

Event Description

A pt was treated based on an incorrect pt's data.The incorrect pt's data was a tachycardic rhythm.Fda safety report id# (b)(4).

• Brand Name: GENERAL ELECTRIC TELE AND B450
• Type of Device: MONITOR, PHYSIOLOGICAL PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): GENERAL ELECTRIC
• MDR Report Key: 9653659
• MDR Text Key: 177400251
• Report Number: MW5092659
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2020
• 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