MAUDE Adverse Event Report: SPACELABS HEALTHCARE XHIBIT TELEMETRY RECEIVER

Model Number 96280

Device Problem Intermittent Communication Failure (4038)

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

Event Date 12/12/2023

Event Type  malfunction  

Event Description

The customer reported that during patient monitoring, three telemetry patients went offline on the xhibit central station.There was no patient or user harm associated with this event.

Manufacturer Narrative

The customer was able to temporarily resolve the failure by reseating the quad receiver card (qrc) in the xhibit telemetry receiver (xtr).The issue has been isolated to the xtr, investigation is ongoing.A follow up report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Manufacturer Narrative

The customer reported that the initial issue was due to the xhibit telemetry receiver (xtr) not recognizing one of the quad receiver cards (qrc).The customer biomed moved the qrc to a different xtr and stated the issue was resolved.The biomed has declined any further assistance with troubleshooting and declined repair at this time.

• Brand Name: XHIBIT TELEMETRY RECEIVER
• Type of Device: XHIBIT TELEMETRY RECEIVER
• 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: 18500022
• MDR Text Key: 333110630
• Report Number: 3010157426-2024-00005
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

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: 96280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 01/30/2024
• 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