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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PRIMUS ANESTHESIA UNITS

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DRÄGERWERK AG & CO. KGAA PRIMUS ANESTHESIA UNITS Back to Search Results
Catalog Number 8603800
Device Problems Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2022
Event Type  malfunction  
Manufacturer Narrative
Based on the available log file, the reported case could be reconstructed. It was found that during the case in question, a sporadic failure of the inspiratory pressure sensor of the vgc (ventilation and gas controller) was detected by the device. In consequence, the ventilator initiated an autonomous shutdown while changing mode (pressure mode) to man/spont accompanied by the corresponding "ventilator fail" alarm as specified. In this case, manual ventilation as well as monitoring function remains unaffected, the user continued ventilation in man/spont. One minute later the automatic ventilation was available again and the procedure was continued towards the end. Dräger finally concludes that the device reacted as specified upon a sporadic failure of the inspiratory pressure sensor. The device was tested according to manufacturers specification and returned into use. The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
 
Event Description
It was reported that a gas machine displayed a ventilator failure message on the screen in use on (b)(6) 2022 at 9:21am. The user was switching between volume mode and pressure mode at the time, in order to overcome some clinical messages the received. After bagging on manual mode for short time, the machine was switched back to volume mode without incient. No injury reported.
 
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Brand NamePRIMUS
Type of DeviceANESTHESIA 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 Key14039797
MDR Text Key297349290
Report Number9611500-2022-00090
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K043607
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8603800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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