MAUDE Adverse Event Report: ICU MEDICAL INC ARTERIAL LINE TRANSDUCER

Catalog Number 43104-07

Device Problem Device Inoperable (1663)

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

Event Date 06/07/2016

Event Type  malfunction  

Event Description

Nurse went to hook up continuous blood pressure monitoring cord to their monitors and was unable to get it to work.The problem was believed to be due it being a closed system transducer.

• Brand Name: ARTERIAL LINE TRANSDUCER
• Type of Device: TRANSDUCER
• Manufacturer (Section D): ICU MEDICAL INC; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 5737712
• MDR Text Key: 47810877
• Report Number: 5737712
• Device Sequence Number: 0
• Product Code: DRS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2016,06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/30/2019
• Device Catalogue Number: 43104-07
• Device Lot Number: 3187410
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1