Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
Catalog Number 8603800
Device Problem Use of Device Problem (1670)
Patient Problem Respiratory Acidosis (2482)
Event Date 09/09/2022
Event Type  Injury  
Event Description
It was reported that there was a gas measurement issue ("discordance of tco2 values and arterial gasometry") and respiratory acidosis of the patient.It was further reported that the patient is currently in icu.Based on current state of knowledge, it could not be excluded that the reported hospitalization was prolonged due to the reported acidosis.Based on a preliminary log analysis, no indications for failures with the gas module were found.On the reported date of event, no case was logged either either, only the power-on self-test of the primus device was performed.Neither were indications for a device malfunction found during on-site checking in follow-up to the event.Nevertheless, a use-related issue leading to the serious injury could not be excluded.
 
Manufacturer Narrative
The investigation has been started; results will be provided within the follow-up report.
 
Event Description
It was reported that there was a gas measurement issue ("discordance of tco2 values and arterial gasometry") and respiratory acidosis of the patient.It was further reported that the patient is currently in icu.Based on current state of knowledge, it could not be excluded that the reported hospitalization was prolonged due to the reported acidosis.Based on a preliminary log analysis, no indications for failures with the gas module were found.On the reported date of event, no case was logged either either, only the power-on self-test of the primus device was performed.Neither were indications for a device malfunction found during on-site checking in follow-up to the event.Nevertheless, a use-related issue leading to the serious injury could not be excluded.
 
Manufacturer Narrative
The date of event was requested and confirmed to be (b)(6) 2022.Based on the logfile however, as already reported within the initial report, the device was not in use on the reported date of event.For that date, only three entries are available showing that the device has been started with a cold start two times and one performed power-on self-test.However, there was no actual case with any selected modes or connected patient logged.All in all, also prior to the confirmed date of event, no indications for a device malfunction were found that could have explained the reported symptom.The primus device is equipped with an integrated patient gas monitoring.This ensures that deviations from set/expected gas readings like etco2 are obvious for the user and that alarms are given according to the alarm limits adjusted by the user.Neither ventilation nor gas delivery would be affected if gas measurement was disturbed because gas readings are not used for control purpose.Finally, the reported issue could neither be confirmed nor reconstructed.There were no indications for a performed case on the confirmed date of event found either.Neither were any indications for a device malfunction found that could have explained the reported gas measurement issue.During on-site checking in follow-up to the event, the gas module was tested to specification and no problem with the gas measurement was found.It could therefore be excluded that the device contributed to the reported serious injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PRIMUS
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 Key15508892
MDR Text Key300875015
Report Number9611500-2022-00255
Device Sequence Number1
Product Code BSZ
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 11/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number8603800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/19/2022
Initial Date FDA Received09/29/2022
Supplement Dates Manufacturer Received11/17/2022
Supplement Dates FDA Received11/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
-
-