MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS ULTRAVIEW SL COMMAND MODULE; ULTRAVIEW SL MULTIPARAMETER MODULE

Model Number 91496

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Tachycardia (2095)

Event Date 12/21/2018

Event Type  malfunction  

Manufacturer Narrative

Spacelabs has been unable to validate this complaint or to conduct an investigation into this matter due to the lack of data available for inspection.There have been no further complaints reported by this customer.This report is complete and this particular issue is considered closed.

Event Description

Spacelabs received a report on (b)(6) 2018 that a patient monitor alarmed for tachycardia, but the hospital¿s nursing staff feel that the alarm should have been for ventricular tachycardia.No injury was reported associated with this issue.

• Brand Name: SPACELABS ULTRAVIEW SL COMMAND MODULE
• Type of Device: ULTRAVIEW SL MULTIPARAMETER MODULE
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: beth benner rn ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635568
• MDR Report Key: 8253269
• MDR Text Key: 133336661
• Report Number: 3010157426-2019-00004
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K103142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/01/2005,01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 91496
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 12/21/2018
• 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