MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. ULTRAVIEW 1050; DETECTOR AND ALARM, ARRHYTHMIA

Model Number 90369

Device Problem Device Alarm System (1012)

Patient Problem No Information (3190)

Event Date 10/23/2016

Event Type  malfunction  

Event Description

Unit did not alarm during asystole, both on the unit and the central station.

• Brand Name: ULTRAVIEW 1050
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 s.e. center st.; snoqualmie WA 98065
• MDR Report Key: 6188538
• MDR Text Key: 62824624
• Report Number: 6188538
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/15/2016,12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 90369
• Device Catalogue Number: 20099967
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR