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 OXYLOG 3000; VENTILATORS, TRANSPORT
  • 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 OXYLOG 3000; VENTILATORS, TRANSPORT Back to Search Results
Catalog Number 2M86300
Device Problems Disconnection (1171); Structural Problem (2506); Detachment of Device or Device Component (2907); Device Fell (4014)
Patient Problem No Patient Involvement (2645)
Event Date 07/30/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation was started.The results will be provided in a follow up report.
 
Event Description
It was reported that the holding claw of the oxylog 3000 broke.No injury reported.
 
Manufacturer Narrative
The onsite investigation result built the basis for the investigation.However the broken holding claw was not available.An exact root cause analysis was therefore not possible.We do not have a report that the oxylog 3000 had been dropped or was in use when the fault was discovered, however it is possible that in case of a falling device a person nearby could be injured.The holding claw is designed to withstand ten times the maximum weight of a fully equipped oxylog carrying system.The affected oxylog 3000 was manufactured in august 2007.The number of similar cases, related to the same failure pattern, is within the expected range of the respective risk assessment and thus accepted.
 
Event Description
Please see initial report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OXYLOG 3000
Type of Device
VENTILATORS, TRANSPORT
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM  23542
MDR Report Key10640683
MDR Text Key210172450
Report Number9611500-2020-00350
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K062267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2M86300
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-