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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL GMBH INFINITY ACUTE CARE SYSTEM; PATIENT MONITOR
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DRAEGER MEDICAL GMBH INFINITY ACUTE CARE SYSTEM; PATIENT MONITOR Back to Search Results
Model Number M540
Device Problems Device Alarm System (1012); Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/20/2014
Event Type  malfunction  
Event Description
It was reported that while the patient was prepared for an internal transport an m540 patient monitor was connected to the patient.The monitor reportedly indicated a changed battery, but while connecting the cables it turned off.The user does not remember whether the device generated an alarm.After that another m540 was taken to monitor the patient.During the transport, after about 3 minutes, this monitor turned off, too.According to the user it notified the user about the critical battery-charge with a red battery symbol and gave an acoustical alarm.There was no injury reported.
 
Manufacturer Narrative
The investigation is ongoing.We will provide results in a separate follow up report.
 
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Brand Name
INFINITY ACUTE CARE SYSTEM
Type of Device
PATIENT MONITOR
Manufacturer (Section D)
DRAEGER MEDICAL GMBH
moislinger allee 53-55
luebeck 23542
GM  23542
Manufacturer Contact
frank clanzett
moislinger allee 53-55
luebeck 23542
GM   23542
18822868
MDR Report Key3804573
MDR Text Key20653733
Report Number9611500-2014-00023
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K092788
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/26/2014
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 Model NumberM540
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/27/2014
Initial Date FDA Received02/26/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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