MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY CENTRAL STATION; PHYSIOLOGICAL MONITORING SYSTEMS

Catalog Number	MS32504
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the infinity central station (ics) shut-down due to an accidental power loss.As per report, the monitoring of the individual patients via their bedplace monitors was not interrupted; the event did not have medical consequences.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : ongoing.
Event or Problem Description
It was reported that the infinity central station (ics) shut-down due to an accidental power loss.As per report, the monitoring of the individual patients via their bedplace monitors was not interrupted; the event did not have medical consequences.
Additional Manufacturer Narrative
The dispatched dräger service engineer could verify in interviews with the users that the shut-down of the infinity central station (ics) was related to an accidental unplugging from the wall outlet socket; function of the ics could be restored after the event by simply plugging it back in.The disconnection from electrical power fully explains that no alarm at all could be generated at the ics anymore and, the system has no capability to alarm a power loss.When connection to the dedicated ics gets lost (network issue or ¿ like in this case, power loss of the ics), the bedside monitors continue to monitor the patients.All m300 devices will display a banner indicating that connection to the ics got lost.Furthermore, the volume of audio alarms will be changed to 100% autonomously, independent from the setting defined before.In addition to that, the setting to 100% cannot be overruled manually by the user for the duration of the connection loss to the ics.Dräger finally concludes that there was no issue with the used devices which would require repair or correction ¿ the reported event was caused by unintended use error (unplugging the ics).The associated risk is under control since the primary monitors at the bedside respond to the connection loss by adaptation of the audio alarm volume.The connectivity loss is indicated by a dedicated banner in the display of each bedside device that belongs to this care unit.As a preventive measure, it is recommended to connect the ics to an uninterruptible power supply.

• Brand Name: INFINITY CENTRAL STATION
• Common Device Name: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 2156602400
• MDR Report Key: 17884039
• Report Number: 9611500-2023-00350
• Device Sequence Number: 20685509
• Product Code: MHX
• UDI-Device Identifier: 04049098004190
• UDI-Public: 04049098004190
• Combination Product (Y/N): N
• PMA/510(K) Number: K061379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: MS32504
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown