MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INNOVIAN; VARIOUS INSTRUMENTS FOR ANESTHESIA AND PULMONARY VENTILATION SUPPORT - SOFTWARE

Catalog Number MS20026

Device Problems No Apparent Adverse Event (3189); Patient Data Problem (3197)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : ongoing.

Event Description

It was reported that a nurse was attempting to document an administered medication dose to a specific patient record but noticed after entering the information into the innovian system that the information was recorded for a different patient instead.It was verified that only the recording of information went wrong; the patients have received correct medications.

• Brand Name: INNOVIAN
• Type of Device: VARIOUS INSTRUMENTS FOR ANESTHESIA AND PULMONARY VENTILATION SUPPORT - SOFTWARE
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 9784470587
• MDR Report Key: 18452151
• MDR Text Key: 332729648
• Report Number: 1220063-2024-00001
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/05/2024

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 Catalogue Number: MS20026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1