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

Catalog Number	MS25520
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information was requested, however; a response was not received.It was not stated upon initial reporting that the patient experienced a serious injury or required medical intervention as a result of the reported issue.No device was returned to the manufacturer for physical evaluation or logs for visual inspection.Without the device or information, it is not possible to perform root cause analysis.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
The customer reported that the m540 was not correctly reading an infant's o2 saturations.The m540 showed that the infant had a o2 saturation of 37%, however; the patient was awake and conscious, with a normal heart rate and not showing low o2 symptoms.The customer replaced the o2 saturation probe, and the reading remained the same.The biomed stated that there is no event/patient information as the devices were received on their desk with no additional information.There is no information stating there is any adverse patient impact or delay in treatment.
Additional Manufacturer Narrative
Additional information was requested, however; a response was not received.It was not stated upon initial reporting that the patient experienced a serious injury or required medical intervention as a result of the reported issue.No device was returned to the manufacturer for physical evaluation or logs for visual inspection.Without the device or information, it is not possible to perform root cause analysis.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
The customer reported that the m540 was not correctly reading an infant's o2 saturations.The m540 showed that the infant had a o2 saturation of 37%, however; the patient was awake and conscious, with a normal heart rate and not showing low o2 symptoms.The customer replaced the o2 saturation probe, and the reading remained the same.The biomed stated that there is no event/patient information as the devices were received on their desk with no additional information.There is no information stating there is any adverse patient impact or delay in treatment.

• 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 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 9784828529
• MDR Report Key: 18889192
• Report Number: 1220063-2024-00028
• Device Sequence Number: 7774142
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)210907(93)MS25520-65
• Combination Product (Y/N): N
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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 Catalogue Number: MS25520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2021
• 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