MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY DELTA; PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Model Number	MS18597
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Event or Problem Description
On 1jun2023 it was reported to a dräger technician that an event occurred with a dräger infinity delta patient monitor mounted to a dräger primus anesthesia workstation where it was reported that the monitor did not alarm and the involved patient died.The customer is not providing further information until their internal investigation is completed.On 5jun2023 dräger received a user facility report regarding the event in which ventilation problems during a surgery performed with a combination of a dräger primus anesthesia workstation and a dräger delta patient monitoring system were mentioned.As further information is not currently available, we are considering the allegation to be against both the primus and the delta.Remark: since the product responsibility for the used devices is with two different manufacturing sites in the dräger organization, two files for the documentation of investigation have been opened: internal reference # (b)(4) (mdr 9611500-2023-00213) for the primus anesthesia workstation and # (b)(4) (mdr 1220063-2023-00018) for the delta patient monitoring system.
Additional Manufacturer Narrative
It was confirmed to dräger during the course of investigation that the patient died.The customer added the information that a breathing filter of type safestar 55 plus was used in the set-up, too.The primus anesthesia workstation was tested by dräger in follow-up of the event against full scope of specifications and, no deviations could be found.The log file covering the period in question could be analyzed which did not reveal any indication for the potential presence of a device malfunction.It can be derived from the logs that the ventilation was unremarkable in the beginning but that disturbances occurred during the wake-up phase after the dosage of volatile anesthetics was stopped.The device has posted appropriate alarms to indicate the measured deviations from the set ventilation parameter.The log further indicates that the device was used for other surgeries afterwards which substantiates the conclusion that there was/is no issue with the device which would require repair or correction.The delta patient monitor was tested by a third-party service provider whereby no deviations from specification were determined.There was no log information in regard to monitored parameter and potential alarms issued by the monitor available anymore since the patient was released from monitoring which erases all data.The error log does not contain any entry for the relevant period which leads to the conclusion that the device worked as intended during the concerned procedure.The breathing filter was not handed over to dräger for evaluation so far.Dräger concludes the following: the exact root cause for the disturbance of ventilation cannot be determined on the base of the available information.The log file for the primus indicates that the device has delivered as set and that the procedure was uneventful until the wake-up phase started.The dosage of volatile anesthetics was active between start of procedure at 09:25 am until approx.10:00 am.In the following, ventilation was disturbed which triggered numerous alarms at the workstation.The patient was disconnected from the device after 1pm.Dräger concludes that there was room to react upon the alarms posted by the device.There was no event data for the patient monitor available but from the fact that no nonconformities were found during testing in follow-up is concluded that the device worked as intended during the course of event.No statement in regard to the breathing filter can be made since it was not made available to dräger.H3 other text : device was tested by third-party service provider.
Event or Problem Description
On 1jun2023 it was reported to a dräger technician that an event occurred with a dräger infinity delta patient monitor mounted to a dräger primus anesthesia workstation where it was reported that the monitor did not alarm and the involved patient died.The customer is not providing further information until their internal investigation is completed.On 5jun2023 dräger received a user facility report regarding the event in which ventilation problems during a surgery performed with a combination of a dräger primus anesthesia workstation and a dräger delta patient monitoring system were mentioned.As further information is not currently available, we are considering the allegation to be against both the primus and the delta.Remark: since the product responsibility for the used devices is with two different manufacturing sites in the dräger organization, two files for the documentation of investigation have been opened: internal reference # (b)(4) (mdr 9611500-2023-00213) for the primus anesthesia workstation and # (b)(4) (mdr 1220063-2023-00018) for the delta patient monitoring system.

• Brand Name: INFINITY DELTA
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 9783798000
• MDR Report Key: 17098795
• Report Number: 1220063-2023-00018
• Device Sequence Number: 1932078
• Product Code: MHX
• UDI-Device Identifier: 04049098004152
• UDI-Public: 04049098004152
• Combination Product (Y/N): N
• PMA/510(K) Number: K070566
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MS18597
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2008
• 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.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 36 YR
• Patient Sex: Male