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 PERSEUS A500; 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 PERSEUS A500; ANESTHESIA UNITS Back to Search Results
Catalog Number MK06000
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 08/16/2022
Event Type  malfunction  
Event Description
The initial log analyses confirmed that there was a failure of the pressure measurement which resulted in an autonomous shutdown of the ventilator and a corresponding ventilator failure alarm.No injury has been reported.However, in case the breathing pressure (incl.Peep) drops to ambient, a deterioration in state of health cannot be excluded for patients with difficult lung/ventilation conditions.
 
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Manufacturer Narrative
A service technician checked the device after the event.Based on the electronic log files she determined that there was failure of the sensor board m4.6.She replaced the board including it¿s sensors and the respective cables / connectors.The electronic log file as well as the replaced sensor board were returned for further in depth analysis.The case in question could be reconstructed by means of the log entries.The procedure started at 08:06am on the reported date of event.Ventilation was unremarkable until the persues detected an interruption of the internal communication to the sensor board.The device reacted as specified for this failure and generated a corresponding pressure sensor failure alarm and stopped automatic ventilation which goes along with a separate ventilator failure alarm.The returned sensor board was installed in a laboratory device setup and tested for two consecutive weeks without recurrence of the failure.Finally the exact root cause could not be determined.A temporary failure of the sensor board itself or an intermittent contact of the replaced cable connection are possible root causes.Both sensor boards and cables were replaced.The device was tested according to dräger specification after the repair.The failure rate of the sensor board is continuously monitored and considered acceptable.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.
 
Event Description
The initial log analyses confirmed that there was a failure of the pressure measurement which resulted in an autonomous shutdown of the ventilator and a corresponding ventilator failure alarm.No injury has been reported.However, in case the breathing pressure (incl.Peep) drops to ambient, a deterioration in state of health cannot be excluded for patients with difficult lung/ventilation conditions.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PERSEUS A500
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 Key15435640
MDR Text Key303745345
Report Number9611500-2022-00238
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675253600
UDI-Public(01)04048675253600(11)210319(17)211027(93)MK06000-39
Combination Product (y/n)N
PMA/PMN Number
K133886
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
Report Date 11/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMK06000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-