MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC ULTRAVIEW; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number 90367

Device Problems Use of Incorrect Control/Treatment Settings (1126); Use of Device Problem (1670)

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

Event Date 02/28/2021

Event Type  No Answer Provided  

Event Description

Monitor for bedspace not communicating with central monitor in front of unit.Unable to monitor remotely.In-house biomed follow up: customer reported not communicating with central monitor, unable to add bed.Confirmed unable to add bed.Found setting not configured correctly to match monitor.Reconfigured settings to match monitor.Connected to network and added bed to central monitor.Verified proper operation and returned device to service.

• Brand Name: ULTRAVIEW
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): SPACELABS HEALTHCARE INC; 35301 se center street; snoqualmie WA 98065
• MDR Report Key: 11494806
• MDR Text Key: 240108398
• Report Number: 11494806
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 90367
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1