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

Device Problems No Display/Image (1183); Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2013

Event Type  malfunction  

Event Description

For approximately 20 minutes, 3 central station monitors blacked out every 2-3 minutes and then came back on-line.A fourth monitor, in a patient room, powered down by itself.Nurse turned monitor back on and the waveforms re-appeared.No patients were harmed.This facility has had several problems with this equipment over the last several months.The manufacturer has been notified of each event and multiple reports have been filed.

• Brand Name: SPACELABS
• Type of Device: MONITOR, CARDIAC
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 5150 220th ave se; issaquah WA *
• MDR Report Key: 3631498
• MDR Text Key: 18572164
• Report Number: 3631498
• 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 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1