MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS ULTRAVIEW SL COMMAND MODULE; ULTRAVIEW SL MULTIPARAMETER MODULE

Model Number 91496

Device Problem Device Alarm System (1012)

Patient Problem Ventricular Tachycardia (2132)

Event Date 07/22/2016

Event Type  malfunction  

Manufacturer Narrative

Onsite testing of the involved devices was conducted by a spacelabs field service engineer confirmed that the equipment performed to specifications.The testing was witnessed by a hospital representative.The retrospective patient database was sent to spacelabs for evaluation.Spacelabs will file a supplemental report once the investigation is complete.

Event Description

Spacelabs received a report that on (b)(6) 2016 at 10:06 a.M.An episode of ventricular tachycardia (vtach) did not alarm at the bedside monitor.No one was injured as a result of this event.

Manufacturer Narrative

The patent's historical waveforms and trend information were reviewed by a spacelabs lead software engineer.The analysis shows that only one lead was monitored and the monitor was set to adult mode.Single lead monitoring reduces the data available for analysis.The artifact detection algorithm in adult mode detected the episode as artifact resulting in no detection of the qrs complexes during the vtach.Hence, the monitor did not alarm for a run of ventricular tachycardia.This report is considered final and the issue is closed.

• Brand Name: SPACELABS ULTRAVIEW SL COMMAND MODULE
• Type of Device: ULTRAVIEW SL MULTIPARAMETER MODULE
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: john zeng ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635915
• MDR Report Key: 5889755
• MDR Text Key: 53572722
• Report Number: 3010157426-2016-00074
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 91496
• Other Device ID Number: 2.03.06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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