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

Catalog Number	MS26372
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was started; results will be provided in a follow up-report.
Event or Problem Description
It was reported the m540 was not giving ekg readings.The m540 was swapped out - approx 30 seconds in delay to patient treatment with no reported injury.
Additional Manufacturer Narrative
It was reported the m540 was no longer displaying ecg/ekg readings.A draeger fse (field service engineer) went onsite to evaluate the m540 unit but was unable to verify/duplicate the reported issue.As the ecg/ekg cable were discarded prior to evaluation, a precise root cause could not be determined however, the reported issue is consistent with faulty ecg/ekg cable set.The fse performed device checks iaw draeger ipm-l service procedures then was able to verify proper ecg readings were displaying on the m540.It was confirmed all tests passed draeger specifications then the unit was returned to service.
Event or Problem Description
It was reported the m540 was not giving ekg readings.The m540 was swapped out - approx 30 seconds in delay to patient treatment with no reported injury.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS INC; 6 tech drive; andover MA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS INC; 6 tech drive; andover MA
• Manufacturer Contact: 6 tech drive; andover, MA ; 2156602400
• MDR Report Key: 18757152
• Report Number: 1220063-2024-00023
• Device Sequence Number: 6271289
• Product Code: MHX
• UDI-Device Identifier: 04049098009751
• UDI-Public: (01)04049098009751(11)210913(93)MS26372-54
• Combination Product (Y/N): N
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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): Initial
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2021
• 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