MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Model Number	MS25520
Medical Device Problem Codes	No Audible Prompt/Feedback (2282); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Event or Problem Description
It was reported that the spo2 alarm (on or off) is not stored in the iacs cockpit profile.The spo2 alarm is activated (on) and saved in the profile.When the patient is admitted after discharge (calling up the default profile), the spo2 alarm is deactivated again (off).Only when the profile is also saved in the m540 is the spo2 alarm automatically activated (on) when monitoring is started.The instructions for use gives no indication of this.Assessment of the situation: potential danger to the patient, as the spo2 alarm may be inadvertently deactivated.No adverse patient impact was reported.The infinity acute care system (iacs) includes an infinity medical cockpit paired with an infinity m540 bedside monitor.Involved infinity m540, ms20401, serial number (b)(6).
Event or Problem Description
It was reported that the spo2 alarm (on or off) is not stored in the iacs cockpit profile.The spo2 alarm is activated (on) and saved in the profile.When the patient is admitted after discharge (calling up the default profile), the spo2 alarm is deactivated again (off).Only when the profile is also saved in the m540 is the spo2 alarm automatically activated (on) when monitoring is started.The instructions for use gives no indication of this.Assessment of the situation: potential danger to the patient, as the spo2 alarm may be inadvertently deactivated.No adverse patient impact was reported.The infinity acute care system (iacs) includes an infinity medical cockpit paired with an infinity m540 bedside monitor.Involved infinity m540, ms20401, serial number (b)(6).
Additional Manufacturer Narrative
Draeger engineering reviewed the provided video/device logs and performed testing with a good known infinity acute care system (iacs) with software version vg4.2.Engineering attempted both discharging/readmitting a patient as well as undocking/redocking a m540 then docking a separate m540 to reproduce the reported issue, but each test produced the spo2 alarm being disabled properly on the m540 as saved in the cockpit profile accordingly.It was determined that the issue was consistent with file corruption of the stored profile.The customer was advised to create a new profile and reset the m540 to factory defaults using the service menu to resolve the issue.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• 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
• MDR Report Key: 16820441
• Report Number: 1220063-2023-00010
• Device Sequence Number: 15249106
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)210201(93)MS25520-63
• Combination Product (Y/N): N
• PMA/510(K) Number: K203088
• 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): 07/21/2023

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: MS25520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2020
• 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