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

Model Number 91390

Device Problem Loss of Power (1475)

Patient Problem Death (1802)

Event Date 06/30/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

Spacelabs received a report that on (b)(6) 2020, the monitor powered off during use.And the patient expired during this time biomed was unable to provide bed name or time of occurrence.

Manufacturer Narrative

The device was sent to spacelabs healthcare for further analysis.No fault found with expected device.The monitor was tested for all alarms and worked as expected with both visible and audible indicators present at the monitor.This report is complete and this particular issue is considered closed.

• 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: 10323987
• MDR Text Key: 200373082
• Report Number: 3010157426-2020-00013
• 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: 01/01/2005,08/21/2020

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?: 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: 06/30/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 06/30/2020
• Supplement Dates FDA Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death