MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS HEALTHCARE TELEMETRY RECEIVER; XTR

Model Number 96280

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

Spacelabs has launched an investigation into this event and will file a supplemental report once the investigation is complete.

Event Description

Spacelabs received a report that on (b)(6) 2017 telemetry system went down.No injury was reported as a result of this event.

Manufacturer Narrative

A spacelabs field service engineer was dispatched to the site for further investigation of the issue.Findings show the cause of the issue was the failure of the dedicated d-link network switch.The switch was replaced, restoring communication.The involved devices passed all tests and were restored to service.This report is complete and this particular issue is considered closed.

• Brand Name: SPACELABS HEALTHCARE TELEMETRY RECEIVER
• Type of Device: XTR
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: carolyn hosea ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635924
• MDR Report Key: 6341361
• MDR Text Key: 68045088
• Report Number: 3010157426-2017-00019
• 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
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/03/2017

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/17/2017
• Supplement Dates Manufacturer Received: 01/25/2017
• Supplement Dates FDA Received: 08/03/2017
• 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