MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS SMART DISCLOSURE SYSTEM; FULL DISCLOSURE SYSTEM

Model Number 92810

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Spacelabs received a report from the nurse about a possible failure to alarm.A patient death was reported with this event.

Manufacturer Narrative

A spacelabs healthcare technical support engineer remotely connected to the customer site and confirmed alarm history in ics.The technical support engineer also reviewed the elastic network interface (eni) log and confirmed that alarms were processing as expected at the time of the reported event.A spacelabs product support specialist (pss) remotely connected to the customer site and found that the data packets were being dropped at the access layer switch and recommended changing the node id and mac address of the effected bed to resolve the reported issue.A spacelabs field service engineer (fse) was dispatched to further evaluate the reported issue and assist with the troubleshooting recommendations.After performing the recommended troubleshooting, the fse tested all spacelabs equipment involved in the reported event and verified proper operation.Section b5 of the initial report submitted to the fda contained incorrect information about the impact to patient.There was no patient injury or death associated with this event.

Event Description

Spacelabs was notified that the vocera phone system is not receiving alarms generated from room nicu17.The customer confirmed that the bedside and central monitors generated both visible and audible alarm notifications as expected.There was no patient injury reported.

• Brand Name: SPACELABS SMART DISCLOSURE SYSTEM
• Type of Device: FULL DISCLOSURE SYSTEM
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: matthew esparza ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635512
• MDR Report Key: 13320315
• MDR Text Key: 286497802
• Report Number: 3010157426-2022-00002
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 92810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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