MAUDE Adverse Event Report: ICU MEDICAL, INC; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Use of Device Problem (1670)

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

Event Date 12/03/2019

Event Type  malfunction  

Event Description

Tubing attached to spiros which was attached to patient.

Event Description

Tubing attached to spiros which was attached to patient.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC
• MDR Report Key: 9510351
• MDR Text Key: 172439922
• Report Number: 9510351
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2019
• Patient Sequence Number: 1