MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS ULTRAVIEW 1050 MONITOR; ULTRAVIEW PATIENT MONITOR

Model Number 90369

Device Problem No Display/Image (1183)

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

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Spacelabs received a medwatch report forwarded from fda that that on (b)(6) 2021 a spacelab monitor screen went black while monitoring a premature patient.The nurse attempted to reboot the monitor but was not successful.After reseating the module, the monitor screen returned to normal.There was no injury as a result of this event, this issue is under investigation.

Manufacturer Narrative

No patient injury reported.The hospital biomed reported that he reported that he inspected monitor, tested, verified proper operation, and inspected monitor with no issues.The device remains in service at the customer site.Spacelabs field service engineer and regulatory reporting specialist made several attempts to follow up with the customer for additional information, none was provided.This report is complete, and this issue is considered closed.A supplemental report will be submitted should additional information become available.H3 other text: placeholder.

• Brand Name: SPACELABS ULTRAVIEW 1050 MONITOR
• Type of Device: ULTRAVIEW PATIENT MONITOR
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• MDR Report Key: 11386162
• MDR Text Key: 238614843
• Report Number: 3010157426-2021-00014
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): Y
• PMA/PMN Number: K972282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,04/29/2021

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: 90369
• 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: 02/19/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 90369 (B)(6).