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

Model Number 96102

Device Problem Defective Alarm (1014)

Patient Problem Ventricular Tachycardia (2132)

Event Date 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

Spacelabs was not able to collect the alarm logs from the central station due to the customer¿s delay in reporting the issue.The customer did provide a photo of the data in clinical access showing an extended run of ventricular tachycardia occurring from 8:20:00-8:20:10 on (b)(6) 2020.There was no vtach alarm recorder in the any logs for the waveform shown in the photo and it is unlikely that the condition would have been detected given the signal noise condition present in the photo.Spacelabs service technicians have tested the monitor that was used at the time of the alleged event and the device passed all functional testing.Due to the lack of data, further investigation is not possible.This report is complete and this particular issue is considered to be closed.

Event Description

On 4 february 2020 spacelabs received an email reporting that a telemetry patient experienced vtach on (b)(6) 2020 at 8:21am but no alarms sounded.

• 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
• Manufacturer Contact: david geraghty ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635889
• MDR Report Key: 9792977
• MDR Text Key: 223726734
• Report Number: 3010157426-2020-00004
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K122146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/01/2005,03/04/2020

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
• Is the Reporter a Health Professional?: Yes
• 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: 02/04/2020
• Initial Date FDA Received: 03/05/2020
• 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
• Patient Age: 69 YR
• Patient Weight: 83