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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
Model Number MS20401
Device Problems Self-Activation or Keying (1557); Failure to Read Input Signal (1581)
Patient Problem Insufficient Information (4580)
Event Date 01/19/2022
Event Type  malfunction  
Event Description
It was reported that the m540 reboots itself, will go into standby mode by itself and the touchscreen does not work.No adverse patient impact was reported.A device that goes into standby mode by itself could result in a patient inadvertently not being monitored/a failure to provide alarms.
 
Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
 
Manufacturer Narrative
The device was sent to draeger service for evaluation and repair.Inspection found that although the screen was unresponsive to touch, it was sending multiple random signals to the processor which caused the reported events.Draeger service replaced the touch screen and top cover.The device was then tested and passed all tests.The device was returned to the customer.Since the device was returned there have been no reports of further issues.No trend has been identified for this issue.
 
Event Description
It was reported that the m540 reboots itself, will go into standby mode by itself and the touchscreen does not work.No adverse patient impact was reported.A device that goes into standby mode by itself could result in a patient inadvertently not being monitored/a failure to provide alarms.
 
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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
6 tech drive
andover MA
Manufacturer (Section G)
DRAEGER MEDICAL SYSTEMS, INC
6 tech drive
andover MA
MDR Report Key13484445
MDR Text Key290063296
Report Number1220063-2022-00003
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04049098054454
UDI-Public04049098054454
Combination Product (y/n)N
PMA/PMN Number
K113798
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMS20401
Device Catalogue NumberMS20401
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/17/2017
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
IACS SYSTEM, M540 PT MONITOR ASSOCIATED COCKPIT; IACS SYSTEM, M540 PT MONITOR ASSOCIATED COCKPIT
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