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

Model Number 91390

Device Problems Defective Alarm (1014); Loss of Power (1475); Low Battery (2584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2017

Event Type  malfunction  

Manufacturer Narrative

The product was received at spacelabs¿ equipment service center for repair.The reported problem was verified and the cpu pcba was replaced.The repaired unit passed all functional tests and was returned to the customer.Spacelabs'' repair records indicate that this is an isolated incident.This report is complete and this particular issue is considered closed.

Event Description

Spacelabs received a report that on (b)(6) 2017 a monitor powered off while monitoring a patient due to battery depletion, but a low battery alarm did not generate prior to this occurrence.No injury was reported as a result of this event.

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: 6777588
• MDR Text Key: 82711900
• Report Number: 3010157426-2017-00059
• 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: user facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 08/09/2017
• Supplement Dates Manufacturer Received: 07/10/2017
• Supplement Dates FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2014
• 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