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

Catalog Number	MS25643
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that on (b)(6) 2024 at approximately 9am, the draeger m540 will not stay connected to the c700 cockpit.It was noticed that there was communication lost to c700 from m540, and the m540 was replaced with a backup unit and the case continued with no further issues.There was no adverse event or patient injury reported.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Event or Problem Description
The customer reported that on (b)(6) 2024 at approximately 9am, the draeger m540 will not stay connected to the c700 cockpit.It was noticed that there was communication lost to c700 from m540, and the m540 was replaced with a backup unit and the case continued with no further issues.There was no adverse event or patient injury reported.
Additional Manufacturer Narrative
It was reported to draeger that the m540 disconnected from the cockpit.The m540 was returned to drager for repair, and it was determined that the mainboard was not recognizing the wireless card, causing the loss of communication.Root cause was identified as faulty mainboard.The mainboard was replaced to resolve the issue.The m540 was tested and returned to the customer.No further issues have been 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
• Manufacturer Contact: 3135 quarry road; telford, PA ; 2156602400
• MDR Report Key: 18677304
• Report Number: 1220063-2024-00013
• Device Sequence Number: 12611266
• Product Code: MHX
• UDI-Device Identifier: 04049098054409
• UDI-Public: (01)04049098054409(11)141219(93)MS25643-05
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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: MS25643
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: NA.
• Patient Sex: Unknown