• 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 APOLLO; ANESTHESIA UNIT

  • 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 APOLLO; ANESTHESIA UNIT Back to Search Results
Catalog Number 8606500
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 08/23/2022
Event Type  malfunction  
Manufacturer Narrative
Log file evaluation performed by the manufacturer confirms the reported behavior: the supervisor function detected a sporadic loss of the signal from the sensor that monitors the pressure inside the cylinder of the piston ventilator.To protect the patient from potentially hazardous output the device is designed to shut-down automatic ventilation and to post a corresponding alarm to alert the user.Manual ventilation with the built-in breathing bag remains possible; the monitoring functions are still available as well.As confirmed for the particular case the device indicates when the signal of the pressure sensor is being detected again and automatic ventilation would be availble - the user could continue with automatic ventilation one minute later.It could not be determined by log file analysis what the exact root cause for the sporadic signal loss of the sensor was.The device was tested in follow-up of the event and did not exhibit any persisting malfunction.A reasonable explanation would be that humidity in the breathing gas has disturbed the function of the sensor for a short time.Dräger finally concludes that the workstation responded as designed upon the deviation.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 the device suddenly posted a ventilator failure alarm during use.As per report, the message went away quickly and the device could be further used.No patient consequences have resulted from the short-term interrupt.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
APOLLO
Type of Device
ANESTHESIA UNIT
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 Key15585951
MDR Text Key301550378
Report Number9611500-2022-00277
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675229674
UDI-Public(01)04048675229674(11)210127(17)250605(93)8606500-68
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
Report Date 10/12/2022
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 Number8606500
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/14/2022
Initial Date FDA Received10/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-