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 Problems Decrease in Pressure (1490); Inaccurate Delivery (2339); Gas/Air Leak (2946); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/21/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
It was reported that he device posted alarms during use on a patient and that automatic ventilation did not work.The patient was transferred to another ventilator.No patient consequences have reportedly occurred.
 
Manufacturer Narrative
The event was reported with one month delay to dräger and, the device remained in use.It took another 4 weeks to secure the log file and thus, the section in which alarms and user interactions are recorded was already overwritten for the period in question.The error log section does not contain any entry that would point to a malfunction of the device.There are however numerous entries which indicate partly massive leaks in the patient circuit outside the device.During the dispatch to secure the log file the dräger service engineer has performed a self-test with the device which was passed without deviations.Due to unavailable log file data for the time of event, a reliable conclusion in terms of root cause for the event can't be drawn.Reflecting the facts - absence of malfunction during on-site check, no recorded technical error codes and the aspect that the device remained in use after the event - it is seen likely that there is no issue with the device which would require repair or correction.The workstation is equipped with pressure and flow monitoring which will trigger corresponding alarms if the effects of leakages in the pneumatic circuit exceed the compensation capabilities of the device.All types of alarms, potential root causes and dedicated remedies are listed in the ifu.
 
Event Description
It was reported that he device posted alarms during use on a patient and that automatic ventilation did not work.The patient was transferred to another ventilator.No patient consequences have reportedly occurred.
 
Manufacturer Narrative
Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.
 
Event Description
It was reported that he device posted alarms during use on a patient and that automatic ventilation did not work.The patient was transferred to another ventilator.No patient consequences have reportedly occurred.
 
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 23542
GM  23542
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM   23542
MDR Report Key11972649
MDR Text Key258637969
Report Number9611500-2021-00248
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675041436
UDI-Public(01)04048675041436(11)200213(93)8603800-95
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 05/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8603800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-