MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY CENTRAL STATION; PHYSIOLOGICAL MONITORING SYSTEMS

Model Number MS26800

Device Problem No Visual Prompts/Feedback (4021)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of this investigation.

Event Description

It was reported that a draeger ics infinity central station was generating only an acoustic alarm.According to the user this alarm was not displayed directly on one of the monitors of the central station at a bedside, nor at an iacs bedside.It appears only acoustically and cannot be assigned to a unit or a bedside.No adverse patient impact reported.

Manufacturer Narrative

Dräger could witness a second event of the same nature on (b)(6) 2024 and captured log files of the involved devices.Evaluation of these log files has resulted in a better understanding of the conditions that let the error condition come into effect.The new information also triggered a review of the initial reporting decision - dräger comes now to the conclusion that this event is indeed not reportable - the nature of the issue is that a false-positive acoustical alarm will be posted at the infinity central station when the triggering conditions are fulfilled.Due to the fact that the alarm cannot be traced to a specific bed place there is no risk for potential misdiagnosis or incorrect treatment in consequence of that.Furthermore, the likelihood for occurrence of all contributing factors at a time is remote.The investigation will be continued.

Event Description

It was reported that a draeger ics infinity central station was generating only an acoustic alarm.According to the user this alarm was not displayed directly on one of the monitors of the central station at a bedside, nor at an iacs bedside.It appears only acoustically and cannot be assigned to a unit or a bedside.No adverse patient impact reported.

• Brand Name: INFINITY CENTRAL STATION
• Type of Device: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 2156602400
• MDR Report Key: 17599813
• MDR Text Key: 321728041
• Report Number: 1220063-2023-00028
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: 04049098001878
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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: MS26800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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