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

Model Number 91393

Device Problem Intermittent Communication Failure (4038)

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

Event Date 02/18/2024

Event Type  malfunction  

Manufacturer Narrative

The customer stated they believed the connection between the monitor and module was loose as the video form the module dropped whenever the monitor was moved.The customer was advised to contact their biomed to troubleshoot the connection between the module and monitor.At this time, we have not received confirmation from the customer regarding additional troubleshooting at the customer site.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 while monitoring on a bedside monitor, the multi-parameter module would intermittently sign off and drop all patient waveforms.There was no patient or user harm associated with this 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: 18938059
• MDR Text Key: 338081569
• Report Number: 3010157426-2024-00040
• 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,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/18/2024

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: 91393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2024
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• 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