MAUDE Adverse Event Report: SPACELABS HEALTHCARE (WASHINGTON), INC TRULINK; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number 90496

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2021

Event Type  malfunction  

Event Description

Monitor unable to take blood pressure (bp) despite changing b/p cable, cuff and monitor box.No patient harm.(this was one of a set of twins) see other twin report same day.Biomed in-house findings: found inflation error when trying to test nibp (non-invasive blood pressure) because of leaky bp hose.Replaced with known working bp hose.Successfully tested nibp.

• Brand Name: TRULINK
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): SPACELABS HEALTHCARE (WASHINGTON), INC; 35301 se center street; snoqualmie WA 98065
• MDR Report Key: 11347852
• MDR Text Key: 232546595
• Report Number: 11347852
• Device Sequence Number: 1
• Product Code: DXN
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 90496
• Device Catalogue Number: 700-0029-00
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1