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

Model Number 91496

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Loss Of Pulse (2562)

Event Date 10/11/2018

Event Type  Death  

Manufacturer Narrative

Onsite testing by a spacelabs field service engineer shows that the involved devices passed all tests.The alarm and waveform history was collected by the fse for further analysis by a spacelabs lead software engineer.Findings show that the asystole event was detected by the device, however due to user defined alarm configurations, no alarm was generated.There was no evidence of device malfunction.This report is complete and this issue is considered closed.

Event Description

Spacelabs received a report on (b)(6) 2018 that on (b)(6) 2018, the nurses reported they saw the monitor with heart rate at "0" and ¿???¿.They reported no alarms at the bedside nor the central station.

• 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: david geraghty ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635889
• MDR Report Key: 8075639
• MDR Text Key: 127338854
• Report Number: 3010157426-2018-00101
• 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
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 91496
• Was Device Available for Evaluation?: Yes
• 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: 10/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2013
• 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
• Patient Outcome(s): Death
• Patient Age: 46 YR
• Patient Weight: 54