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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY M300; PHYSIOLOGIC MONITORING SYSTEM
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DRAEGER MEDICAL SYSTEMS, INC INFINITY M300; PHYSIOLOGIC MONITORING SYSTEM Back to Search Results
Catalog Number MS25755
Device Problems No Audible Prompt/Feedback (2282); Communication or Transmission Problem (2896)
Patient Problem Arrhythmia (1721)
Event Date 12/10/2023
Event Type  Injury  
Event Description
It was reported that the patient left the ward on the doe at approx.5am.The patient was found on the floor in their room between 7 and 8am and in need of resuscitation.After re-entering the ward, the m300 obviously did not go online again.Patient is in the intensive care unit; according to the doctor, the patient has not suffered any further damage as a result of this incident.
 
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : ongoing.
 
Event Description
It was reported that the patient left the ward on the doe at approx.5am.The patient was found on the floor in their room between 7 and 8am and in need of resuscitation.After re-entering the ward, the m300 obviously did not go online again.Patient is in the intensive care unit; according to the doctor, the patient has not suffered any further damage as a result of this incident.
 
Manufacturer Narrative
The user facility provided two (b)(4) units for evaluation because they were not able to clearly identify the device which was involved into the event.The units could not be tested in detail because this requires the connection of a data cable to the spo2 port which was defective at both devices - it is thus unclear if both devices were able to establish network connection or not.The faulty spo2 port has no causal connection to a potential loss of network connection - it is just the case here that dräger is unable to verify if network communication with these two (b)(4) units works in general.Log files for the devices covering the period in question were not provided by the customer.Logs for the infinity central station were available for evaluation.The entries show that one m300 on ward m3 lost network connection during the period in question.The entries in the logs show that other m300s also repeatedly were losing connection to the ics as well.Although the involved device could not be identified due to lack of information, the logs of the ics provide evidence that one m300 used in this ward lost network connection.The loss of network connection triggered a corresponding audible and visual alarm at the ics.Due to the fact that the particular patient was reportedly moving around, it cannot be excluded that he went to an area of weak network signal strength.On the other hand, there's evidence that other m300 units lost connection to the central station as well - it would thus also be imaginable that the signal quality and stability of the network is insufficient.Dräger concludes that the ics behaved as specified for this error condition - an offline message and a corresponding audio alarm were posted upon loss of connection to the bed place.It is under responsibility and control of the user to respond in a timely manner upon technical alarms.
 
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Brand Name
INFINITY M300
Type of Device
PHYSIOLOGIC MONITORING SYSTEM
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 
9783798000
MDR Report Key18363926
MDR Text Key330990451
Report Number1220063-2023-00052
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04049098048989
UDI-Public(01)04049098048989(11)200609(93)MS25755-29
Combination Product (y/n)N
PMA/PMN Number
K151860
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMS25755
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/12/2023
Initial Date FDA Received12/20/2023
Supplement Dates Manufacturer Received03/07/2024
Supplement Dates FDA Received03/07/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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