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 Problems Death (1802); Ventricular Fibrillation (2130)

Event Date 12/06/2019

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 december 6th, 2019 that on (b)(6) 2019 a patient went into a ventricular fibrillation heart rhythm.The customer reported that this heart rhythm was incorrectly categorized by the monitor as a pause, which is a medium priority alarm, instead of the high priority alarm that should have been generated for ventricular fibrillation.The customer reports that the patient subsequently died.

Manufacturer Narrative

No failure was found.The command module recognized an episode of bradycardia that transitioned to asystole and ventricular tachycardia several times and then generated a series of medium and high priority alarms for several hours.The information suggests that this series of alarms ended when ecg alarms were manually disabled for several hours by a user.This report is complete, and the case is considered 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
• Manufacturer Contact: beth benner rn ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635568
• MDR Report Key: 9548132
• MDR Text Key: 173646639
• Report Number: 3010157426-2019-00042
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K103142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• 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
• 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: 01/14/2005
• 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
• Treatment: 91496 (1496-109256)91393 (1393-002170)
• Patient Outcome(s): Death