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

Model Number 96102

Device Problem Device Alarm System (1012)

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 07/11/2021

Event Type  malfunction  

Manufacturer Narrative

Spacelabs has launched an investigation and will file a supplemental report when the investigation is complete.

Event Description

Spacelabs received a report on july 14th, 2021, that on (b)(6) 2021, at 7 pm a patient stopped breathing and a code was called.No alarms occurred at the central.The hospital wants a full backup of the data from ics taken and analyzed for alarmable conditions.

Manufacturer Narrative

The investigation found no device failure in the patient's historical database.The xtr telemetry system recognized the patient¿s ecg waveform changed and then appropriately generated a series of medium and high priority alarms also found in the xhibit device log.This report is complete, and this issue is considered closed.

• Brand Name: SPACELABS XHIBIT CENTRAL STATION
• Type of Device: XHIBIT CENTRAL MONITOR
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• MDR Report Key: 12219473
• MDR Text Key: 265671779
• Report Number: 3010157426-2021-00042
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): Y
• PMA/PMN Number: K122146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/03/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death