MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY DOCKING STATION; COMPUTER INTERFACE

Catalog Number	MS18597
Medical Device Problem Codes	No Device Output (1435); Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing; results will be provided in a follow-up report.H3 other text : on-going.
Event or Problem Description
It was reported that the patient monitor lost the co2 trace during an anesthetic procedure and was alarming for battery error.The delta patient monitor was connected via an infinity docking station (ids) to a dräger fabius anesthesia workstation; the gas readings were provided by a dräger scio anesthetic gas monitor.It was mentioned in the report that the event did not lead to consequences for the patient.
Additional Manufacturer Narrative
A draeger technician went on site and localized the reported issues to a failed power supply which was replaced.No further issues have been reported.
Event or Problem Description
It was reported that the patient monitor lost the co2 trace during an anesthetic procedure and was alarming for battery error.The delta patient monitor was connected via an infinity docking station (ids) to a draeger fabius anesthesia workstation; the gas readings were provided by a draeger scio anesthetic gas monitor.It was mentioned in the report that the event did not lead to consequences for the patient.

• Brand Name: INFINITY DOCKING STATION
• Common Device Name: COMPUTER INTERFACE
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 9784470587
• MDR Report Key: 18401266
• Report Number: 1220063-2023-00054
• Device Sequence Number: 16837374
• Product Code: MHX
• UDI-Device Identifier: 04049098004152
• UDI-Public: (01)04049098004152(11)190321(93)MS18597-66
• Combination Product (Y/N): N
• PMA/510(K) Number: K050974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: MS18597
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown