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

Model Number 91390

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959)

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

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Spacelabs received a report on (b)(6) 2018 that the qube monitor shut down while monitoring a patient, had multiple error messages, and reset itself.No injury was reported with this event.

Manufacturer Narrative

The qube compact monitor was received at spacelabs¿ equipment service center for repair where the reported problem was verified.The printed circuit board assembly with power supply was replaced.The repaired unit passed all functional tests and was returned to the customer.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
• Manufacturer Contact: michael frey ; 35301 se center st.; snoqualmie, WA 98065 ; 425 363-56
• MDR Report Key: 7373857
• MDR Text Key: 103945987
• Report Number: 3010157426-2018-00042
• 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
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/27/2018
• Supplement Dates Manufacturer Received: 03/05/2018
• Supplement Dates FDA Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2016
• 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