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

Model Number 91496

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2020

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 that a uvls customer reported that the command module stops functioning with loss of ecg when nobody had turned them off intentionally.No injury was reported with this event.

Manufacturer Narrative

The hospital reported no patient injury.The patient''s historical waveforms and trend history had been purged from the device when the customer reported it to spacelabs and was no longer available for investigation.We are unable to investigate further due to a lack of information, including device identifying information.This report is complete, and this issue is considered closed.Spacelab will submit a supplemental report should additional information become available.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: 10590851
• MDR Text Key: 213482575
• Report Number: 3010157426-2020-00036
• 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: 01/01/2005,08/19/2021

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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 09/04/2020
• Supplement Dates FDA Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1