MAUDE Adverse Event Report: SPACELABS HEALTHCARE SPACELABS ULTRAVIEW SL COMMAND MODULE

Model Number 91496

Device Problem Device Alarm System (1012)

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

Event Date 01/16/2023

Event Type  malfunction  

Manufacturer Narrative

A spacelabs healthcare field service engineer (fse) was dispatched to evaluate the reported issue.The fse has coordinated with the customer to retrieve the data from the event so a retrospective review of the ics data could be performed. at this time, the ics data has not been received.A follow up report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

The customer reported that a bedside failed to alarm for a high heart rate on bedside monitor.There was no patient or user death, or injury associated with the event.

• Brand Name: SPACELABS ULTRAVIEW SL COMMAND MODULE
• Type of Device: SL COMMAND MODULE
• 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 ; 4253635701
• MDR Report Key: 16369478
• MDR Text Key: 309467301
• Report Number: 3010157426-2023-00016
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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