MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. INFINITY CENTRAL STATION; PATIENT MONITOR

Model Number MS25707

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2014

Event Type  malfunction  

Event Description

It was reported that 2 m300s appeared to display inaccurate pt waveforms at the infinity central station (ics) and at the m300a.It was reported that at approx 7:00am on (b)(6) 2014, the m300 from bed 61 displayed what appeared to be a vtach rhythm and at approx 10:00am on the same day, the m300 from bed 62 also began to display what appeared to be a vtach rhythm.It was reported that a nurse responded to the pts and a cardizem drip was started although the nurse reported that in each case, the pt did not show symptoms of irregular rhythm and the nurse did not detect the displayed rhythm when listening to the pt's heart.There were no injuries reported.(b)(4).

Manufacturer Narrative

Draeger is still investigating the reported incident.A f/u report will be submitted as soon as the investigation has been completed.

• Brand Name: INFINITY CENTRAL STATION
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA 18969
• Manufacturer Contact: rebecca dolloff ; 6 tech drive; andover, MD 01812-2434 ; 9783798573
• MDR Report Key: 3961445
• MDR Text Key: 4563216
• Report Number: 1220063-2014-00019
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2014

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: Health Professional
• Device Model Number: MS25707
• Initial Date Manufacturer Received: 05/07/2014
• Initial Date FDA Received: 05/29/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1