MAUDE Adverse Event Report: SPACELABS HEALTHCARE ULTRAVIEW TELEMETRY MODULE; TELEMETRY RECEIVER

Model Number 90478

Device Problem Complete Loss of Power (4015)

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

Event Date 12/22/2022

Event Type  malfunction  

Manufacturer Narrative

A spacelabs field service engineer (fse) went on site to investigate the reported issue.During the evaluation, it was found that the antenna system did not have power to it.Through further investigation, it was found that the facility's uninterruptible power supply (ups) had failed.Once the fse plugged the antenna system to the emergency wall outlet, proper device operation was observed.The cause of the reported issue was isolated to a failure ups.

Event Description

A customer reported that on multiple telemetry floors lost telemetery beds at their central stations.No patient harm or user harm associated with this event.

• Brand Name: ULTRAVIEW TELEMETRY MODULE
• Type of Device: TELEMETRY RECEIVER
• Manufacturer (Section D): SPACELABS HEALTHCARE; 35301 se center st; snoqualmie WA 98065
• Manufacturer (Section G): SPACELABS HEALTHCARE; 35301 se center st; snoqualmie WA 98065
• Manufacturer Contact: whitney snyder ; 35301 se center st; snoqualmie, WA 98065 ; 4255594957
• MDR Report Key: 16199876
• MDR Text Key: 308015479
• Report Number: 3010157426-2023-00005
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2022
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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