• 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; ANESHESIA 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; ANESHESIA UNITS Back to Search Results
Catalog Number 8603800
Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/06/2021
Event Type  malfunction  
Manufacturer Narrative
The log file was analyzed whereby it was determined that the device passed the automatic power-on self-test (post) in the morning of the date of event without deviations.The respective surgical procedure ran stable and unremarkable for approx.40 minutes until the self-monitoring function detected a communication problem between the cpu board that controls the gas dosage and the user interface.In a situation where ventilator and gas mixer enter a fail state simultaneously the supervisor software routine is designed to switch-off both subsystems.The device went into the so-called "safety mode" and alerted the user to this condition by means of a corresponding alarm.If such deviation occurs during use the user has to set up an adequate oxygen and a-gas flow manually to perform manual ventilation with the in-built breathing bag; monitoring functionalities of the device are not affected by this kind of error condition.The procedure how to establish the emergency gas supply is laid down in the ifu.Dräger knows a certain number of similar events - none of these events could be traced back to a clear root cause.The fact that the identical type of board is used in the workstation twice and does not exhibit malfunctions in the second application periphery makes a general design issue rather unlikely.A reasonable explanation would be electrostatic discharge of the user during interaction with the device or any other kind of electromagnetic disturbance that exceeds the immunity barriers of the device.The primus was developed in compliance to the requirements of iec 60601-1-2.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.
 
Event Description
It was reported that the device failed during use accompanied by a gas mixer failure alarm.The patient needed to be manually ventilated.No patient consequences have been reported.
 
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 the device failed during use accompanied by a gas mixer failure alarm.The patient needed to be manually ventilated.No patient consequences have been reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PRIMUS
Type of Device
ANESHESIA 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 Key12369649
MDR Text Key271491464
Report Number9611500-2021-00355
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 05/31/2022
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 Number8603800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/10/2021
Initial Date FDA Received08/26/2021
Supplement Dates Manufacturer Received08/10/2021
Supplement Dates FDA Received06/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-