MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS ULTRAVIEW SL COMMAND MODULE; ULTRAVIEW SL MULTIPARAMETER MODULE

Model Number 91496

Device Problems Device Operates Differently Than Expected (2913); Operating System Becomes Nonfunctional (2996)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2015

Event Type  malfunction  

Event Description

Spacelabs received a report that on (b)(6) 2014 command module model 91496 (sn (b)(4)) experience several resets which froze the masimo oxygen saturation parameter on the qube bedside monitor model 91390 before the system completely stopped working.No one was injured as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

The involved devices were returned to spacelabs for investigation by a product support specialist.Command module logs confirmed that multiple resets had occurred on the module.The monitor had not logged any resets.The module resets experienced by the customer were triggered by a software memory access error specific to modules with the masimo pcba part number 010-1136-02 for oxygen saturation measurement.Root cause was determined to be a change in the firmware version number communicated by the masimo pcba which was not appropriately processed by the module resident software.The module¿s memory array set up to hold the full version string was not sized to handle the complete range of numbers sent by the masimo pcba.The result of the array overflow was a module reset.A compatible software version for the command module was provided which resolved this issue.This report is considered final and the issue is closed.

• Brand Name: SPACELABS ULTRAVIEW SL COMMAND MODULE
• Type of Device: ULTRAVIEW SL MULTIPARAMETER MODULE
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: john zeng ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635915
• MDR Report Key: 4714348
• MDR Text Key: 19089293
• Report Number: 3010157426-2015-00049
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103142
• 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: 06/14/2015

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 Expiration Date: 01/31/2016
• Device Model Number: 91496
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2015
• Initial Date FDA Received: 04/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2015
• 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