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

Model Number 91390

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

Spacelabs has launched an investigation into this event and will file a supplemental report once the investigation is complete.

Event Description

Spacelabs received a report that on (b)(6) 2017 the bedside monitor shuts off during patient use and would not turn back on.No injury was reported as a result of this event.

Manufacturer Narrative

The device was sent to spacelabs healthcare for further analysis.The reported problem was verified.The power supply pcba was replaced.The repaired unit passed all functional tests and was restored to service.This report is complete and this particular issue is considered closed.

Manufacturer Narrative

This follow-up report is being sent to correct the manufacturer medical device evaluation results code.

• 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: carolyn hosea ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635924
• MDR Report Key: 6316145
• MDR Text Key: 67339620
• Report Number: 3010157426-2017-00016
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2017

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
• Other Device ID Number: V3.05.10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/09/2017
• Supplement Dates Manufacturer Received: Not provided; 01/17/2017
• Supplement Dates FDA Received: 03/14/2017; 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1