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

Model Number	MS25510
Medical Device Problem Code	Capturing Problem (2891)
Health Effect - Clinical Code	Asystole (4442)
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 during use, the infinity acute care system (iacs) often experiences interference.Although the operating room mode has been turned on and the amplitude has been adjusted, there is still a significant amount of interference.Additionally, ecg often generates erroneous signals, including when the heart stops beating during heart surgery, the monitor still has a sine wave waveform, and after the heart restarts, the monitor needs to wait for a long time to recover.No adverse patient impact was reported.The infinity acute care system (iacs) includes an infinity medical cockpit paired with an infinity m540 bedside monitor.
Additional Manufacturer Narrative
It was reported the iacs was intermittently experiencing interference issues.The amplitude in the or room was adjusted but significant interference was still present and the ecg generates erroneous signals as the connection between c500 and m540 is unstable.After a disconnection, a restore of the m540 factory settings then the machine recovers back to a normal connection.Post restoration of the normal alarm, the iacs automatically reverts back to the draeger configuration repeatedly, and the draeger configuration cannot be deleted.An onsite draeger technician found the hospital was using a 5 lead system then replaced that with a 3 lead ecg then performed a software upgrade.It was also confirmed the m500 was not running on firmware 4.0.After the ecg lead replacement and software upgrade, the draeger technician confirmed the reported issue is no longer present and the system was functioning as intended.Several requests were made by the investigator to obtain additional information, but that information was not made available and therefore, a precise root cause could not be determined.
Event or Problem Description
It was reported that during use, the infinity acute care system (iacs) often experiences interference.Although the operating room mode has been turned on and the amplitude has been adjusted, there is still a significant amount of interference.Additionally, ecg often generates erroneous signals, including when the heart stops beating during heart surgery, the monitor still has a sine wave waveform, and after the heart restarts, the monitor needs to wait for a long time to recover.No adverse patient impact was reported.The infinity acute care system (iacs) includes an infinity medical cockpit paired with an infinity m540 bedside monitor.

• 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 ; 2156602400
• MDR Report Key: 17277767
• Report Number: 1220063-2023-00019
• Device Sequence Number: 17014320
• Product Code: MHX
• UDI-Device Identifier: 04049098054409
• UDI-Public: (01)04049098054409(11)171129(93)MS25510-46
• Combination Product (Y/N): N
• PMA/510(K) Number: K093788
• 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): 04/29/2024

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 Model Number: MS25510
• Device Catalogue Number: MS25510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2017
• 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