MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS XPREZZON BEDSIDE MONITOR; S-CLASS MULTIPARAMETER PATIENT MONITOR

Model Number 91393

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022)

Patient Problem Ventricular Tachycardia (2132)

Event Date 07/17/2019

Event Type  malfunction  

Manufacturer Narrative

Spacelabs was able to collect the alarm logs from the central station monitor for the date and time of the alleged event.However, spacelabs has not been able to collect the patient waveforms that correlate with the event date and time reported.The alarm logs showed that there were three alarms that indicate a ¿noisy signal¿, during the two minutes when vtach was reported to have occurred.Without ecg waveforms from that time to compare to the alarm history, it is impossible to determine whether an alarm had or could have occurred, given the signal noise condition.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 sufficient information, further investigation is not possible.This report is complete and this particular issue is considered to be closed.

Event Description

Spacelabs received a report on (b)(4) 2019 that in (b)(6) 2019, an icu patient went into vtach and no audible or visual alarm occurred.There was no reported injury to the patient in association with this incident.

• Brand Name: SPACELABS XPREZZON BEDSIDE MONITOR
• Type of Device: S-CLASS MULTIPARAMETER PATIENT MONITOR
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: beth benner rn ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635568
• MDR Report Key: 8903757
• MDR Text Key: 154939650
• Report Number: 3010157426-2019-00031
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K112962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/01/2005,08/16/2019

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: 91393
• 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: 07/18/2019
• Initial Date FDA Received: 08/16/2019
• 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: 64