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 01/19/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

Spacelabs received a report that on (b)(6) 2018 a patient death involving an asystole rhythm occurred, and no alarm generated on the bedside monitor.

Manufacturer Narrative

Spacelab¿s field service engineer went onsite to investigate incident.Per spacelabs investigative findings and evidenced by the collected patient data, there was no device malfunction.The field service engineer verified that all device parameters and alarms were functional.This report is complete and this particular issue is considered closed.

• 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: michael frey ; 35301 se center st.; snoqualmie, WA 98065 ; 425 363-56
• MDR Report Key: 7282913
• MDR Text Key: 100460314
• Report Number: 3010157426-2018-00019
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

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: 91496
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/20/2018
• Supplement Dates Manufacturer Received: 01/22/2018
• Supplement Dates FDA Received: 03/15/2018
• 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: 91369 (1369-008623)
• Patient Outcome(s): Death