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

Model Number	MS18384
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Tachycardia (2095)
Date of Event	12/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an event where the involved patient died, the nurse noticed that the patient hr went >120, tachycardia and up to 237bpm but no audible alarms were provided at the infinity central station (ics).Though the involved patient died, there is no allegation the ics behavior caused a delay in treatment/played a part in the patient outcome.Infinity m300 (serial number (b)(4)) patient worn monitor was being used with the ics.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Additional Manufacturer Narrative
Note that the date received by manufacturer was initially reported as 20dec2022 in error.The correct date was 19dec2022.It was additionally noted by the user that the arr setting for tach (tachycardia) was set to high, but they could see the ics provided a medium grade tach alarm.Review of the logfile provided for the involved infinity central station (ics) show multiple medium grade alarms for hr (heart rate) > 120, tach and svt (supraventricular tachycardia) had been visually and audibly provided at the ics from the involved m300/tel-1a bed label during the reported timeframe at 07:45:27 to 07:47:08am on the 18th of december 2022.As medium grade alarms are non-latching alarms with a latched message, as explained in the instructions for use (ifu), if the condition clears itself (as the hr>120 did in this event at 7:45:57), the audio and visual flashing alarm signals stop.The visual alarm message is downgraded to a status message which appears in the header bar.The ics audio was tested on site and confirmed to function correctly.Regarding the user reporting that the arrhythmia setting for tachycardia was set to high.The m300 logfile shows the tachycardia alarm was changed to medium grade on the 18th of december 2022 at 18:28:34, the day prior to the event.Therefore, it can be concluded that the involved m300 and infinity central station (ics) alarmed as specified and informed the user accordingly about the patient conditions during the reported event.There was no device malfunction.The customer was provided this information.H3 other text : see h10.
Event or Problem Description
It was reported that during an event where the involved patient died, the nurse noticed that the patient hr went >120, tachycardia and up to 237bpm but no audible alarms were provided at the infinity central station (ics).Though the involved patient died, there is no allegation the ics behavior caused a delay in treatment/played a part in the patient outcome.Infinity m300 (serial number (b)(6) , sw version vg2.4) patient worn monitor was being used with the ics (sw version vg3.0su1).

• Brand Name: INFINITY CENTRAL STATION
• Common Device Name: PHYSIOLOGICAL MONITORING SYSTEM
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• Manufacturer Contact: 6 tech drive; andover, MA
• MDR Report Key: 16051788
• Report Number: 1220063-2022-00021
• Device Sequence Number: 6394270
• Product Code: MHX
• UDI-Device Identifier: 04049098050449
• UDI-Public: 04049098050449
• Combination Product (Y/N): N
• PMA/510(K) Number: K151860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 04/28/2023

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 Model Number: MS18384
• Device Catalogue Number: MS25707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 04/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2015
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 84 KG