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 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

The issue recovered on its own and cause of failure could not be identified.If additional information is made available, a follow up report will be submitted in accordance with 21 cfr 803.56.

Event Description

A spacelabs healthcare product support specialist (pss) contacted the customer to gather additional information.By the time the pss had contacted the customer, it was confirmed that the issue had resolved on it's own.Since the issue had resolved on it's own, the cause could not conclusively be determined.If additional information is made available, a follow up report will be submitted in accordance with 21 cfr 803.56.

• 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: 18000336
• MDR Text Key: 326463173
• Report Number: 3010157426-2023-00083
• 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
• Report Date: 09/26/2023

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: 09/26/2023
• Initial Date FDA Received: 10/24/2023
• 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