MAUDE Adverse Event Report: ICU MEDICAL, INC DISPOSABLE TRANSDUCER; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Device Problem High Readings (2459)

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

Event Date 05/14/2019

Event Type  malfunction  

Event Description

Arterial blood pressure read 300/212 after the a-line was calibrated/zeroed.Blood pressure readings continued to be greater than 300 after calibration with perfect waveform.Patient was asymptomatic.Nibp reading was 114/51.Transducer changed and blood pressure readings were 148/50, 142/50.

• Brand Name: DISPOSABLE TRANSDUCER
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 8752484
• MDR Text Key: 149782457
• Report Number: 8752484
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31390 DA