MAUDE Adverse Event Report: MERGE HEALTHCARE INC. MERGE HEMO; COMPUTER, DIAGNOSTIC, PROGRAMMER

Model Number VERSION 10.0.4.4395.DC

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/08/2019

Event Type  malfunction  

Event Description

Marge hemo device was reading pt's pulse / heart rate as "0".Pt had to be placed on the defibrillator monitor to capture the correct pt's heart rates.Udi ((b)(4), version: 10.0.4.4395.Dc.

• Brand Name: MERGE HEMO
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMER
• Manufacturer (Section D): MERGE HEALTHCARE INC.
• MDR Report Key: 8443939
• MDR Text Key: 139603311
• Report Number: MW5085069
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• 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: 03/19/2019

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
• Device Model Number: VERSION 10.0.4.4395.DC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2019
• 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: 76 YR
• Patient Weight: 88