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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY CENTRAL STATION; PHYSIOLOGICAL MONITORING SYSTEM
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DRAEGER MEDICAL SYSTEMS, INC INFINITY CENTRAL STATION; PHYSIOLOGICAL MONITORING SYSTEM Back to Search Results
Device Problems Device Alarm System (1012); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/07/2019
Event Type  Death  
Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
 
Event Description
It was reported that during a patient event at approximately 1:13 in the morning, the m300 tele 4 did not transmit an asystole alarm to the infinity central station.The resuscitation team of the intensive care unit was informed at 1:15, after that the alarms were audible.It was reported that the patient is dying, whether there is a connection between this event and the patient's condition is unknown.Additional details provided: device is operated with blackbox extender acu5116.Ics is located in the server room, it was checked that the alarms arrive at the intensive station and station 13a.An inspection of the entire system will be done after commissioning by the hospital's medical technology department next monday.Until then, the entire system will not be used.The ics log has been saved.The patient has already been discharged from the m300.Logs therefore no longer available, no events for the above mentioned time in event mode, long-term data printout attached.User also complains about a faulty power cable of the central charger (date: (b)(6) 2019), but presumably not related to this event).It was replaced by the medical technology of the house, then in the central charger asystole alarms were triggered on several m300 devices.The patient didn't have a pacemaker.
 
Event Description
It was reported that during a patient event at approximately 1:13 in the morning, the m300 tele 4 did not transmit an asystole alarm to the infinity central station.The resuscitation team of the intensive care unit was informed at 1:15, after that the alarms were audible.It was reported that the patient is dying, whether there is a connection between this event and the patient's condition is unknown.Additional details provided: device is operated with blackbox extender acu5116.Ics is located in the server room, it was checked that the alarms arrive at the intensive station and station 13a.An inspection of the entire system will be done after commissioning by the hospital's medical technology department next monday.Until then, the entire system will not be used.The ics log has been saved.The patient has already been discharged from the m300.Logs therefore no longer available, no events for the above mentioned time in event mode, long-term data printout attached.User also complains about a faulty power cable of the central charger (date: (b)(6) 2019), but presumably not related to this event).It was replaced by the medical technology of the house, then in the central charger asystole alarms were triggered on several m300 devices.The patient didn't have a pacemaker.
 
Manufacturer Narrative
Additional information was provided that the patient was reanimated but later died.M300 logs were not available to identify the specific alarms generated.Full disclosure and ecg strip were reviewed and no asystole condition was seen.Furthermore, the ics logs do not indicate the user was actively silencing alarms at the time of event which agrees with the full disclosure and ecg strips, as no events were generated or detected.Based on the available information, the issue could not be verified, and no malfunctions were determined to have occurred with draeger¿s products.Both the m300 and the ics were tested prior to being put back into use and no problems were found.The issue is isolated.There is no information that indicates our device played a factor in the patients death.
 
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Brand Name
INFINITY CENTRAL STATION
Type of Device
PHYSIOLOGICAL MONITORING SYSTEM
Manufacturer (Section D)
DRAEGER MEDICAL SYSTEMS, INC
6 tech drive
andover MA 01810 2434
MDR Report Key8964919
MDR Text Key156798078
Report Number1220063-2019-00016
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
PMA/PMN Number
K130711
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/25/2019
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 Expiration Date01/01/2000
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/12/2019
Initial Date FDA Received09/05/2019
Supplement Dates Manufacturer Received08/12/2019
Supplement Dates FDA Received11/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death; Life Threatening;
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