MAUDE Adverse Event Report: SPACELABS HEALTHCARE XHIBIT CENTRAL STATION; CENTRAL STATION REMOTE MONITOR

Model Number 96102

Device Problem Communication or Transmission Problem (2896)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

A spacelabs healthcare product support specialist (pss) gathered the device logs from the xhibit central station to investigate the reported issue.During a review of the logs, there was no evidence of a device malfunction or abnormality related to the reported issue.Currently, the pss is working with the customer to further investigate the reported issue.A follow up mdr will be submitted in accordance with 21 cfr 803.56 when the additional information is available.

Event Description

The customer reported to spacelabs healthcare that when they were moving some patients around on their xhibit central station, others would disappear.There was no harm to the patients or user reported.

• Brand Name: XHIBIT CENTRAL STATION
• Type of Device: CENTRAL STATION REMOTE 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: akshaya parmar ; 35301 se center st; snoqualmie, WA 98065
• MDR Report Key: 19001362
• MDR Text Key: 338923849
• Report Number: 3010157426-2024-00055
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 96102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2023
• 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