MAUDE Adverse Event Report: SPACELABS HEALTHCARE XPREZZON MONITOR; MULTIPARAMETER PATIENT MONITOR

Model Number 91393

Device Problem Power Problem (3010)

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

Event Date 08/24/2023

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fse) evaluated the system where they were unable to verify the reported issue.The customer had reported that there were no gaps seen in clinical access, indicating that restarts were instantaneous.The fse retrieved the error logs from the device and provided them to the product support specialist (pss) for additional investigation.The pss evaluated the logs and was able to confirm some instances of power failures being logged, indicating a sudden loss of power.When discussing the findings in the error log with the customer, it was confirmed that the facility was having power issues on the portion of the building where these devices were located during that time.It's likely that the rebooting of the monitors was related to the facility power issue.

Event Description

The customer reported that seven bedside monitors were randomly rebooting while in use.There was no patient or user death, or injury associated with the event.

• Brand Name: XPREZZON MONITOR
• Type of Device: MULTIPARAMETER PATIENT MONITOR
• 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
• MDR Report Key: 17822269
• MDR Text Key: 324334317
• Report Number: 3010157426-2023-00070
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 91393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• 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