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

Model Number	N/A
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
The investigation has started.A follow up report will be submitted upon completion.
Event or Problem Description
It was reported the non-invasive blood pressure (nibp) cuff was used on a patient to obtain a nibp reading.The reading was low but within the minimum acceptable range, so the nurse decided not to give the patient fentanyl boluses for pain management.The following day, the same cuff was used to obtain another nibp reading but the reading was very low, which prompted the user to inspect the cuff.During their inspection it was found the cuff had small tears along the velcro.The user expressed concerns that these tears could have impacted the accuracy of the nibp reading.No adverse patient impact was reported.
Additional Manufacturer Narrative
The report of false measurements from the non-invasive blood pressure (nibp) cuff could not be confirmed.The nibp cuff was returned to draeger for evaluation.A simulator was used to test the cuff and was set to 38/15 and the draeger cuff measured 39/15.The infinity m540 nibp static cuff accuracy range is +/- 3 mmhg (as per the instruction for use).The readings of the draeger cuff in comparison to the simulated nibp of 38/15 fall within the expected accuracy range (35/12 ¿ 41/18).Therefore, draeger was unable to verify the reported inaccurate measurements with this cuff.
Event or Problem Description
It was reported the non-invasive blood pressure (nibp) cuff was used on a patient to obtain a nibp reading.The reading was low but within the minimum acceptable range, so the nurse decided not to give the patient fentanyl boluses for pain management.The following day, the same cuff was used to obtain another nibp reading but the reading was very low, which prompted the user to inspect the cuff.During their inspection it was found the cuff had small tears along the velcro.The user expressed concerns that these tears could have impacted the accuracy of the nibp reading.No adverse patient impact was reported.

• 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 ; 9784090504
• MDR Report Key: 23451392
• Report Number: 1220063-2025-00054
• Device Sequence Number: 9174463
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)201208(93)MS20401-30
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: N/A
• Device Catalogue Number: MS20401
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2020
• 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