MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS; MONITOR, CARDIAC

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2013

Event Type  malfunction  

Event Description

Patient was being transported back to his room on a transport monitor.Moved the module to the bedside monitor and the screen was blank.Tried re-seating the module, tried using a different port- still blank.Called spacelabs customer support and they were unable to help.Left message for the rep to call.Called customer service again an hour later- couldn't reach anyone.Ended up putting the pt on a different brand monitor.No injury to patient.

• Brand Name: SPACELABS
• Type of Device: MONITOR, CARDIAC
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st; snoqualmie WA 98065
• MDR Report Key: 3631479
• MDR Text Key: 4179850
• Report Number: 3631479
• Device Sequence Number: 1
• Product Code: DRT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/27/2014

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: Invalid Data
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2014
• Patient Sequence Number: 1