MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS QUBE COMPACT MONITOR

Model Number 91390

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Code Available (3191)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

The reported condition was verified.Spacelabs technical support investigation verified with customer the device worked as expected for the reported event.Training on remote view functionality was provided, and the same equipment remains in use by the customer.This report is complete, and this issue is considered closed.

Event Description

Spacelabs received a report that on (b)(6) 2020 an issue with xtr remote views on bedside monitors reappearing unintentionally when there is a new patient on the bedside or tele bed.The unexpected display of information caused the clinician to delay patient treatment leading to prolonged stress on the patient¿s heart and unnecessarily prolonged hospitalization.

• Brand Name: SPACELABS QUBE COMPACT MONITOR
• Type of Device: QUBE COMPACT MONITOR
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: marc rivas ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635568
• MDR Report Key: 10353782
• MDR Text Key: 202778321
• Report Number: 3010157426-2020-00017
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K120616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/01/2005,07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 91390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 07/31/2020
• 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