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 INFINITY ACS WORKSTATION CC; VENTILATORS, INTENSIVE CARE
  • 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 INFINITY ACS WORKSTATION CC; VENTILATORS, INTENSIVE CARE Back to Search Results
Catalog Number 8416400
Device Problems Complete Blockage (1094); Gas Output Problem (1266); Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Encephalopathy (1833); Hypoxia (1918)
Event Date 12/16/2019
Event Type  Injury  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow up-report.
 
Event Description
It was reported that the device posted "airway obstructed" while in use on patient.The user said that the ventilation was obstructed for 15 minutes.It was reported that the patient suffered a hypoxic encephalopathy.
 
Manufacturer Narrative
The log file of the affected device was provided for the investigation.The log entries show that prior to the event on the reported date of event no device check or breathing circuit check was performed in preparation of the ventilation.Around the reported time of event several alarm messages concerning "airway obstructed?", "leakage", "mv low" and "vt high" were posted.There is no indication of a device malfunction.An obstruction could be caused e.G.By the patient condition or an issue with the patient breathing circuit.The device reacted as specified to this situation by posting a visual and audible alarm.
 
Event Description
It was reported that the device posted "airway obstructed" while in use on patient.The user said that the ventilation was obstructed for 15 minutes.It was reported that the patient suffered a hypoxicencephalopathy.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INFINITY ACS WORKSTATION CC
Type of Device
VENTILATORS, INTENSIVE CARE
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM  23542
MDR Report Key9502641
MDR Text Key178740754
Report Number9611500-2019-00459
Device Sequence Number1
Product Code CBK
UDI-Device Identifier04048675042266
UDI-Public(01)04048675042266(11)181016(17)190824(93)8416400-19
Combination Product (y/n)N
PMA/PMN Number
K093633
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 02/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number8416400
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-