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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
Device Problems Device Alarm System (1012); Loss of Power (1475); Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/10/2019
Event Type  malfunction  
Manufacturer Narrative
The logs from the time of the event have been requested.The final investigation results will be provided upon completion in a follow up report.
 
Event Description
It was reported after the surgery, the patient was connected to the transport monitor.During the transport first the art monitoring option failed.Afterwards the monitor switched off without alarm.There was no patient harm.
 
Manufacturer Narrative
Regarding the symptom of the art monitoring failure, clarification on the symptom of the failure was requested but determined to not be available.The complete set of the m540 logs was requested multiple times but was not provided.The cited device was tested for functionality of the art parameter and was found to function as designed.No device malfunction regarding this issue could be verified, and the root cause could not be determined.Regarding the symptom of the monitor switching off, after review of the m540 error logs provided, it was found that this was a reboot due to a known software issue where the m540 reboots in response to receiving low accuracy messages from the etco2 pod.A field safety corrective action has been released for this issue, draeger reference (b)(4).This customer was notified of this issue via the field action.The customer was again provided the tsb with the available solutions.
 
Event Description
It was reported after the surgery, the patient was connected to the transport monitor.During the transport first the art monitoring option failed.Afterwards the monitor switched off without alarm.There was no patient harm.
 
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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 01810 2434
MDR Report Key8786157
MDR Text Key150971357
Report Number1220063-2019-00013
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
PMA/PMN Number
K113798
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Recall
Type of Report Initial,Followup
Report Date 08/13/2019
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 Expiration Date01/01/2000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/14/2019
Initial Date FDA Received07/12/2019
Supplement Dates Manufacturer Received06/14/2019
Supplement Dates FDA Received08/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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