MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS XHIBIT CENTRAL STATION; S-CLASS CENTRAL MONITOR

Model Number 96102

Device Problems Nonstandard Device (1420); Loss of Power (1475)

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

Event Date 09/29/2016

Event Type  malfunction  

Manufacturer Narrative

The reported issue has been identified as a software problem.Spacelabs has initiated a field corrective action and notified the fda (b)(6) district office of this action on (b)(6), 2016 (recall number: (b)(4).We also notified customers of this activity with a letter dated (b)(6) 2016.This investigation is considered complete and the issue closed.

Event Description

Spacelabs received a report that on (b)(6) 2016 telemetry beds went offline at the xhibit central monitor.The spacelabs field service engineer resolved the issue by restarting the central.No injury was reported as a result of this event.

• Brand Name: SPACELABS XHIBIT CENTRAL STATION
• Type of Device: S-CLASS CENTRAL MONITOR
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: marc rivas ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635568
• MDR Report Key: 6052692
• MDR Text Key: 58605707
• Report Number: 3010157426-2016-00158
• 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
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/24/2016

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: 96102
• Other Device ID Number: V1.00.00.7972
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2016
• Initial Date FDA Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2015
• 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