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

Model Number 91496

Device Problem Device Alarm System (1012)

Patient Problem Death (1802)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

Spacelabs has initiated an investigation into this matter.A supplemental report will be filed once the investigation is complete.

Event Description

Spacelabs received a report on (b)(6) 2020 for failure to alarm spo2 at neither bedside or central for tcu room 4511 on (b)(6) 2020 around 2:30pm; patient died.

Manufacturer Narrative

The investigations concluded that there was no device malfunction.The patient¿s historical data was reviewed and found a series of medium priority alarms were present at time of reported event.The information present suggests alarms were manually disabled during this sequence.If enabled, we expect there would have been continuous high priority alarm notifications for asystole present at the monitor.Spacelabs field service engineer went on-site to test product, testing could not be completed because the device involved in the complaint episode was in active use at the time of the visit.This report is considered final and the issue closed.H3 other text: placeholder.

• 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
• MDR Report Key: 11043379
• MDR Text Key: 228241576
• Report Number: 3010157426-2020-00055
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): Y
• PMA/PMN Number: K103142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 91496
• Was Device Available for Evaluation?: No
• 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: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death