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

Catalog Number	MS26372
Medical Device Problem Codes	Capturing Problem (2891); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the customers were unable to print diagnostic ecg readings, and that the prints were showing lots of noise or flatline, while the cockpit showed all leads.The logs and wireshark were analyzed and showed that there were no errors.Current on- site practices were reviewed, and it was found that there were some incorrect lead placement practices being utilized.These items were addressed, and the hospital was informed that they need to fix local grounding.The facility is using the new monolead model which seems to be presenting the stated error and not the old leads.While there is no device failure with the monolead itself, there has been a design change request opened to address the functional operation of the lead which addresses the 2nd gen monolead's increased stiffness.
Event or Problem Description
There was no specific event reported - the user facility stated that they were unable to establish 12-lead ecg monitoring for critical patients properly.There was no detail in the report which would reasonably suggest that health consequences for a patient may have occurred.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported by the customer that the m540 has shut down during operation and gave and alarm, and could not be restarted.There was no report of patient injury or death.
Additional Manufacturer Narrative
Further communication found that the previous investigation results needed to be amended.  it was reported that the customers were unable to print diagnostic ecg readings, and that the prints were showing lots of noise or flatline, while the cockpit showed all leads.No network analysis was conducted, and no logs were provided to be analyzed.On site analysis conducted by the local clinical applications specialist(s) found that the department with the issue had wooden parquet flooring, which was not correctly grounded.To resolve the interference issue, the clinical applications specialist informed the customer of the grounding to be corrected and confirmed correct lead placement practices.
Event or Problem Description
There was no specific event reported - the user facility stated that they were unable to establish 12-lead ecg monitoring for critical patients properly.There was no detail in the report which would reasonably suggest that health consequences for a patient may have occurred.
Event or Problem Description
It was reported by the customer that the m540 has shut down during operation and gave an alarm and could not be restarted.There was no report of patient injury or death.
Additional Manufacturer Narrative
Initial mdr 1220063-2024-00053, was created in error.Mdr 1220063-2024-00053 (follow-up 1 and 2) is for patient identifier: (b)(6).Mdr 1220063-2024-00107 (30 day [combined]) is for patient identifier: (b)(6).

• 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 ; 2156602400
• MDR Report Key: 19261581
• Report Number: 1220063-2024-00053
• Device Sequence Number: 6492781
• Product Code: MHX
• UDI-Device Identifier: 04049098009751
• UDI-Public: (01)04049098009751(11)150420(93)MS26372-27
• 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: Physician Assistant
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/13/2024

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: MS26372
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 05/06/2024; 05/21/2024; 08/29/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 05/08/2024; 06/18/2024; 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2015
• 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: N/A.; N/A.; NA.; NA.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown