• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DRÄGERWERK AG & CO. KGAA PRIMUS ANESTHESIA UNITS Back to Search Results
Device Problem Loss of Power (1475)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/07/2019
Event Type  malfunction  
Manufacturer Narrative
The ventilator failure described by the user could be reconstructed by means of the logfile analysis. No indications for a device malfunction were found. The autonomous safety shutdown of the ventilator was triggered by a significantly increased airway pressure peak. The reason for this was an existing lack of fresh gas during the case in combination with spontaneous breathing efforts of the patient. The device behaved as specified with an autonomous shutdown while changing mode to man/spont (safety mode) accompanied by an audible and visible "ventilator fail" alarm. In advance, the user was informed about the fresh gas deficiency and pressure situation (multiple alarms aw. Pressure high / pressure negative / fg low or leak). In order to avoid situations like this in the future, it was recommended to switch on the synchronization for spontaneously breathing patients (e. G. Pressure mode with activated trigger) or use synchronized ventilation mode (e. G. Pressure support). 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 ventilator failure occurred towards the end of the surgery. The patient was reportedly breathing spontaneously. There was no patient injury reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRIMUS
Type of DeviceANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
Manufacturer Contact
sonja hillmer
moislinger allee 53-55
lübeck 23542
GM   23542
4518822868
MDR Report Key8292293
MDR Text Key134882972
Report Number9611500-2019-00031
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675041436
UDI-Public(01)04048675041436(11)160525(93)8603800-90
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K042607
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/31/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-