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

Model Number	MS25520
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
The customer states that there was no ekg tracing on either the m540 or the c700.The b/p and o2 sat readings were still displayed.The customer tried turning the units on and off as well as a new ekg cable and ekg leads.Neither corrected the issue.The m540 was replaced with a different m540 and then ekg tracing was available.There was no report of patient injury or adverse event.
Event or Problem Description
The customer states that there was no ekg tracing on either the m540 or the c700.The b/p and o2 sat readings were still displayed.The customer tried turning the units on and off as well as a new ekg cable and ekg leads.Neither corrected the issue.The m540 was replaced with a different m540 and then ekg tracing was available.There was no report of patient injury or adverse event.
Additional Manufacturer Narrative
It was reported there was no ekg tracing on either the m540 or the c700.The blood pressure and o2 saturation readings were still displaying properly.An attempt was made to hard reboot the m540 and cockpit then replaced the ekg cable and leads but neither resolved the reported issue.Ekg tracings were available once the customer replaced the m540 with a spare.A field service engineer (fse) went onsite to perform testing on the m540 by connecting the device to an ecg simulator where it was confirmed one set of ecg leads were faulty.All other sets of ecg leads were fully functional.The m540 and cockpit were both found to be functioning properly and returned back to service for use.

• 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 ; 9784828529
• MDR Report Key: 18685162
• Report Number: 1220063-2024-00015
• Device Sequence Number: 6396427
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)181102(93)MS25520-51
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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 Expiration Date: 10/24/2018
• Device Model Number: MS25520
• Device Catalogue Number: MS25520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2018
• 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