MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS XHIBIT CENTRAL STATION; XHIBIT CENTRAL MONITOR

Model Number 96102

Device Problem Device Alarm System (1012)

Patient Problem Respiratory Arrest (4461)

Event Date 02/13/2021

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 on (b)(6) 2021 that the volume slider bars are all grayed out.The volume is set to the lowest level.A patient in icu3 coded and nobody heard the alarm.Volume key is locked.

Manufacturer Narrative

No failure was found.The module recognized an episode of desaturation and bradycardia that transitioned to asystole, which then generated a series of medium and high priority alarms.Findings indicated the staff could not hear the alarms due to the low volume.Review of the monitor data indicated this patient generated more than 25 minutes of almost constant alarms during this complaint episode.This report is considered final.H3 other text: placeholder.

• Brand Name: SPACELABS XHIBIT CENTRAL STATION
• Type of Device: XHIBIT CENTRAL MONITOR
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: marc rivas ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635568
• MDR Report Key: 11418256
• MDR Text Key: 239679687
• Report Number: 3010157426-2021-00016
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K122146
• 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: 01/01/2005,11/24/2021

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: 96102
• 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
• Initial Date Manufacturer Received: 02/14/2021
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 02/14/2021
• Supplement Dates FDA Received: 11/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death