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

Model Number 91496

Device Problem Defective Alarm (1014)

Patient Problem Ventricular Fibrillation (2130)

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

Spacelabs has launched an investigation and will file a supplemental report when the investigation is complete.

Event Description

Spacelabs received a report that on (b)(6) 2021 that documented a patient had an episode of ventricular fibrillation in which the monitor did not sound an alarm.No injury was reported with this event.

Manufacturer Narrative

Spacelabs, investigation concluded no failure found.The patient''s historical waveforms and trend history had been purged from the device by the customer and were no longer available for analysis.The field service engineer went onsite and tested the unit.It passed all functional tests, including all visual and audible alarms.We know no reason that audible and visual alarm indicators would not have been present at the central monitor as alarm indicators for the primary monitor operated according to specifications when tested by a spacelabs field service engineer.This report is complete, and this issue is considered closed.Placeholder.

• 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
• MDR Report Key: 11943465
• MDR Text Key: 263468797
• Report Number: 3010157426-2021-00033
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): Y
• PMA/PMN Number: K103142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/13/2021

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
• 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: 05/14/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 05/14/2021
• Supplement Dates FDA Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1