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

Model Number 91393

Device Problem Defective Alarm (1014)

Patient Problem Ventricular Tachycardia (2132)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

Onsite testing by clinical engineering confirmed that the involved devices performed to specifications.The patient's historical waveforms and trend information were reviewed by clinical engineering.Findings showed vtach alarms generated for the reported episode.Clinical engineering tested all devices, tested all alarm tones, verified the monitor and passed all test.The audio settings at the central monitor volume were suspected to be low and therefore for all audio alarms were increased.There is no evidence of malfunction.This report is considered final and the issue is closed.

Event Description

Spacelabs received a report on (b)(6) 2020 that on the (b)(6) 2020, an rn left floor and relinquished watch of patient to another rn, patient went into vtach for 20m before original rn returned.Interim rn stated she never heard the alarm.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: marc rivas ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635568
• MDR Report Key: 10353787
• MDR Text Key: 202934673
• Report Number: 3010157426-2020-00016
• 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
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/01/2005,07/31/2020

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: 91393
• 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: 07/08/2020
• Initial Date FDA Received: 07/31/2020
• 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