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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 Gas Output Problem (1266); Failure to Analyze Signal (1539); Inaccurate Delivery (2339)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation was just started.The results will be forwarded when closing the complaint.
 
Event Description
It was reported that during operation a ventilator failure alarm occured.No patient injury reported.
 
Event Description
It was reported that during operation a ventilator failure alarm occured.No patient injury reported.
 
Manufacturer Narrative
For the investigation the logfile was analysed.It was found that during the power-on self-test (post) repeatedly a problem was detected at the auxiliary vacuum pressure.The post was aborted and the unit was switched into operation.The ventilator again detected the faulty vacuum pressure.To prevent from damages, the system is designed to shut down automatic ventilation and to alert the user to this condition with "ventilator fail".Manual ventilation and the monitoring functions remain available to the full extent.The auxiliary vacuum pressure is needed to operate the valves that control the ventilation cycles and to keep the ventilator diaphragm in place during piston movement.If the vacuum pressure is measured out of range the system reacts with a shutdown of automatic ventilation and generation of a corresponding alarm since a dislocated or wrinkled piston diaphragm may cause significant mechanical damages to the ventilator unit.Reasons for a vacuum pressure out of range can be multiple; a pump issue, an occluded inlet filter, a leakage in the device-internal tubing; perforation of the ventilator diaphragm or issues with the sensor that measures the pressure.However it was not possible to determine the exact root cause.The number of similar cases, related to the same issue, 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 Key14731209
MDR Text Key297536906
Report Number9611500-2022-00149
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675224747
UDI-Public(01)04048675224747(11)170612(17)171109(93)8607500-48
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 09/08/2022
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 Catalogue Number8607500
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/06/2022
Initial Date FDA Received06/17/2022
Supplement Dates Manufacturer Received08/23/2022
Supplement Dates FDA Received09/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2017
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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