MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC.; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2017

Event Type  malfunction  

Event Description

It was reported that during an approximately 2 second power outage, draeger monitoring systems house-wide and a pyxis medication machine did not function.Reportedly, no harm occurred to patients.Reportedly, the cause of the power outage is unknown.Device information not provided as it was a house-wide issue.

• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC.; 6 tech drive; andover MA 01810
• MDR Report Key: 6633187
• MDR Text Key: 77303758
• Report Number: 6633187
• Device Sequence Number: 1
• Product Code: MHX
• 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: Other
• Type of Report: Initial
• Report Date: 05/30/2017

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: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2017
• Type of Device Usage: N
• Patient Sequence Number: 1