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

Catalog Number	MS31422
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
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 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, ms31422, serial number (b)(6).
Event or Problem Description
See initial mfr.Report #.
Additional Manufacturer Narrative
A log file was provided which has been evaluated.The reported condition cannot be confirmed - the spo2 alarm was continuously enabled during the concerned period, multiple instances of active spo2 alarms were logged and, there's also evidence for user interaction with the device - the user has acknowledged spo2 alarms (alarm silence).Indications for the potential presence of a device malfunction were not found.The user facility has reported three similar events to dräger.Within the evaluation of the first complaint, the reported issue could be confirmed: a patient monitor m540 at which the spo2 alarm was disabled during the previous monitoring episode had been docked to the c500 cockpit of another bed place, the standard profile from the cockpit should have been restored to the newly introduced m540.The patient profile has spo2 alarm enabled by default but it was not restored to the m540, the spo2 alarm remained disabled.This was associated to a corrupt profile.It was thus recommended as a result of (b)(4) to re-load new profiles to each device in this care unit.The dräger s&s organization had soon started with this activity but this was not yet completed when the second and third instances of this phenomenon were observed by the user.As a consequence, the entire fleet has been uploaded with new profiles again to exclude that one device may not have been included in the measure and continues to spread the failure.The error condition has not recurred since then.Dräger has provided extensive testing of the conditions in the lab but was not able to duplicate the phenomenon and, it was also not observed at any other site so far.The aspect that the evaluated log file was not containing the same signature like the first one may be explained by the fact that the user wasn't 100% sure which device exhibited the issue the second time - there is a lot of "travelling" of the m540 monitors between the bed places in this ward.

• 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 ; 9783798000
• MDR Report Key: 17832077
• Report Number: 1220063-2023-00033
• Device Sequence Number: 15143505
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)160831(17)161119(93)MS25520-39
• Combination Product (Y/N): N
• PMA/510(K) Number: K203088
• Number of Events Summarized: 1
• Summary Report (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): 12/21/2023

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 Catalogue Number: MS31422
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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