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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PRIMUS INFINITY EMPOWERED; ANESTHESIA UNITS
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DRÄGERWERK AG & CO. KGAA PRIMUS INFINITY EMPOWERED; ANESTHESIA UNITS Back to Search Results
Catalog Number 8607500
Device Problems No Device Output (1435); Failure to Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation was just started.The result will be forwarded as soon the investigation is completed.
 
Event Description
It was reported that the device alarmed failure after the patient was induced with anaestetic agents.The device completely shut down.Technician was called to inspect and switched off the device in order to restart it.Patient was bagged during this time.Device restarted but error was still active: ¿ventilator failure¿.Patient was bagged, no injury reported.
 
Event Description
It was reported that the device alarmed failure after the patient was induced with anaestetic agents.The device completely shut down.Technician was called to inspect and switched off the device in order to restart it.Patient was bagged during this time.Device restarted but error was still active: ¿ventilator failure¿.Patient was bagged, no injury reported.
 
Manufacturer Narrative
For the investigation the logfile was analysed.The described problem could be retraced, it was found that the device was run in battery mode and the device shut down due to a used up battery.During the startup phase of the device the battery life state will be checked by the power supply.In case that the battery is not ok any more the power supply will perform an acoustical alarm for 30 seconds, as it was seen in the logfile in this case.After startup of the device the user will see the discharged battery during power on self test and in normal operation on the screen (battery level 0% in right upper corner).In case of a power supply failure, for example because the power plug is pulled, the device continues operation using the internal backup batteries without limitation of functionality.The remaining capacity of the batteries is indicated to the user and additional warnings are given when the residual battery capacity underruns 20% respectively 10%.The batteries are subject to an aging process and are replaced periodically during product maintenance (each 3 years).In this case the device already displayed the status of an ¿old battery¿ several times before the case in question, the battery was relaced and the device performed as specified.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
 
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Brand Name
PRIMUS INFINITY EMPOWERED
Type of Device
ANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck
GM 
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM   23542
MDR Report Key14050136
MDR Text Key297349021
Report Number9611500-2022-00092
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675224747
UDI-Public(01)04048675224747(11)181212(17)190510(93)8607500-50
Combination Product (y/n)N
PMA/PMN Number
K042607
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 06/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8607500
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
NA.; NA.
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