MAUDE Adverse Event Report: SPACELABS HEALTHCARE XHIBIT TELEMETRY RECIEVER

Model Number 96280

Device Problem Communication or Transmission Problem (2896)

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

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

The spacelabs health care field service engineer (fse) inspected all the relevant network hardware and could not find any faults.Further on site testing is expected with additional assistance from a product support specialist.A follow up report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

A spacelabs healthcare field service engineer (fse) was on site and stated that they observed several telemetry beds going offline for several minutes before coming back online on its own.There was no patient or user harm associated with this event.

• Brand Name: XHIBIT TELEMETRY RECIEVER
• Type of Device: XHIBIT TELEMETRY RECIEVER
• 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: 19001364
• MDR Text Key: 338923675
• Report Number: 3010157426-2024-00045
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/28/2024

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 Operator: Health Professional
• Device Model Number: 96280
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2024
• 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