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

Model Number 91390

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

Spacelabs has launched an investigation and will file a supplemental report when the investigation is complete.Other text : placeholder.

Event Description

Spacelabs received a report that on (b)(6) 2021 incident where a covid patient monitored on a spacelabs qube monitor removed its mask and resulted in patient passing away.Patient was on a qube serial # (b)(4) and command module (b)(4).

Manufacturer Narrative

No failure found.The 91496 command module recognized an episode of bradycardia that transitioned to asystole and generated a series of medium and high priority alarms that were active until all ecg alarms were manually disabled.The 91496-module also recognized an episode of low spo2 that transitioned to desat and generated a series of medium and low priority alarms that were confirmed in the xhibit logs.The module continued to generate spo2 sensor off alarms for the duration of the event in question.This report is complete, and this particular issue is considered closed.H3 other text : placeholder.

• 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
• MDR Report Key: 11721118
• MDR Text Key: 249496460
• Report Number: 3010157426-2021-00025
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): Y
• PMA/PMN Number: K120616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/09/2021

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
• 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: 04/09/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 04/09/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 91390 (1390-126347)
• Patient Outcome(s): Death