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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 Problem Low Readings (2460)
Patient Problems Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2023
Event Type  malfunction  
Event Description
The customer reported that they were monitoring the spo2 readings for a patient (via masimo ear probe) on the m540 and saw that they differed significantly from the abg readings that were taken.The abg readings were 96%-98% when taken and the m540 was reading in the low to mid 80%.They tried a handheld device and another monitor and these readings correlated to the abg numbers.They replaced the m540 and all associated accessories and quarantined for collection by draeger.No adverse patient impact was reported.
 
Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
 
Manufacturer Narrative
The returned m540 units along with the masimo and nellcor pods were evaluated with no malfunction found however, the spo2 sensors were found to be at end of life where the sensor no longer lights up as they have ¿timed¿ out but are not faulty.Masimo programs their sensors for a certain amount of uses and once that limit is reached, the sensor will no longer function.The ifu notes, before connecting the sensor to the patient, visually inspect all components for wear or damage.After connection of the sensor observe monitor for any messages if the sensor does not light up.If sensor-led does not light up, then replace sensor.The masimo country manager went onsite where they could not find any environmental issue that attribute to the reported issue.After an extended stay at the customer site, observing the clinical practice showed no malfunction or evidence that may lead to the m540 spo2 readings differing from the abg results.No further information or investigation into the issue was provided from the customer as the hospital is planning to change to philips monitors.Masimo stated they will no longer be investigating the issue as they have exhausted all options with no issues found.Therefore, root cause of the reported issue could not be determined.
 
Event Description
The customer reported that they were monitoring the spo2 readings for a patient (via masimo ear probe) on the m540 and saw that they differed significantly from the abg readings that were taken.The abg readings were 96%-98% when taken and the m540 was reading in the low to mid 80%.They tried a handheld device and another monitor and these readings correlated to the abg numbers.They replaced the m540 and all associated accessories and quarantined for collection by draeger.No adverse patient impact was reported.
 
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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
3135 quarry road
telford PA
Manufacturer (Section G)
DRAEGER MEDICAL SYSTEMS, INC
3135 quarry road
telford PA
Manufacturer Contact
3135 quarry road
telford, PA 
MDR Report Key16343026
MDR Text Key309401639
Report Number1220063-2023-00004
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04049098054454
UDI-Public(01)04049098054454(11)200226(91)N/A(93)MS20401-30
Combination Product (y/n)N
PMA/PMN Number
K203088
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/09/2023
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 NumberMS20401
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/01/2023
Initial Date FDA Received02/09/2023
Supplement Dates Manufacturer Received05/23/2023
Supplement Dates FDA Received06/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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