MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS ULTRAVIEW SL CENTRAL MONITOR; UVSL CENTRAL MONITOR

Model Number 91387-38

Device Problem Image Display Error/Artifact (1304)

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

Event Date 06/07/2017

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 data and waveforms for the telemetry patients on the central monitor disappeared after the user rebooted the device.Monitoring resumed by deploying a spare central monitor, and no injury was reported as a result of this event.

Manufacturer Narrative

The customer biomed was assisted by spacelabs technical support to investigate the device, and a device memory issue was identified.The customer biomed was advised to replace the cpu board to resolve the issue.There have been no reports of recurrence.This report is considered final and the issue closed.

• Brand Name: SPACELABS ULTRAVIEW SL CENTRAL MONITOR
• Type of Device: UVSL CENTRAL 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 ; 4253635924
• MDR Report Key: 6688493
• MDR Text Key: 79242038
• Report Number: 3010157426-2017-00052
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102422
• 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: 11/07/2017

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: 91387-38
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 07/05/2017
• Supplement Dates Manufacturer Received: 06/07/2017
• Supplement Dates FDA Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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