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

Model Number 91496

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Arrhythmia (1721); Ventricular Fibrillation (2130)

Event Date 01/26/2017

Event Type  malfunction  

Manufacturer Narrative

The spacelabs field service engineer made several attempts to follow up with the customer for additional information, but was unsuccessful.When on site, the field service engineering was unable to access the equipment for testing because the device continued to be used to monitor patients.Because the event was reported to spacelabs 13 days after occurrence, at the time of investigation the patient's record had been purged from the ics database.Additionally, the customer was unable to provide any waveform recordings showing the complaint episode or other information.No recurrences have been reported.This report is complete, and this particular issue is considered closed.

Event Description

Spacelabs received a report that on (b)(6) 2017 that the monitor failed for vfib arrhythmia while in use.No patients were injured as a result of this event.

• 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: marc rivas ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635568
• MDR Report Key: 6390025
• MDR Text Key: 69761866
• Report Number: 3010157426-2017-00025
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/08/2017

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: 91496
• Other Device ID Number: 2.05.12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2017
• Initial Date FDA Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 91393