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

Model Number 91496

Device Problem No Audible Alarm (1019)

Patient Problem Death (1802)

Event Date 07/28/2020

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 that on july 28, 2020, a patient was found yesterday at 4:30 pm with an expired patient that has ecg leads and spo2 cable unplugged from the monitor.The nurse in the unit claimed that no alarms were heard from the monitor in the period from around 3 pm to 4:30 pm.

Manufacturer Narrative

Spacelab''s investigation concluded that tech support found no failure.The ics database reviewed by tech support recognized there was some disruption in recording and lead switching and lead ii remained when the ecg signal stopped.The field service engineer went onsite to test, but it could not be completed because the equipment was in active use at the visit.This report is complete, and this issue 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
• MDR Report Key: 10383154
• MDR Text Key: 204696198
• Report Number: 3010157426-2020-00021
• 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: 01/01/2005,08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2020
• 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: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death