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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
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DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT Back to Search Results
Catalog Number MS25643
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/08/2024
Event Type  malfunction  
Event 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.
 
Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
 
Event 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.
 
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.
 
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Brand Name
INFINITY ACUTE CARE SYSTEM (M540)
Type of Device
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 Key18677304
MDR Text Key335087172
Report Number1220063-2024-00013
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04049098054409
UDI-Public(01)04049098054409(11)141219(93)MS25643-05
Combination Product (y/n)N
PMA/PMN Number
K113798
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 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
Device Operator Health Professional
Device Catalogue NumberMS25643
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/09/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/12/2024
Initial Date FDA Received02/09/2024
Supplement Dates Manufacturer Received05/10/2024
Supplement Dates FDA Received05/10/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
NA.
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