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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA D-VAPOR; ANESTHESIA UNIT VAPORIZERS
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DRÄGERWERK AG & CO. KGAA D-VAPOR; ANESTHESIA UNIT VAPORIZERS Back to Search Results
Catalog Number M35500
Device Problems Overheating of Device (1437); Electrical Overstress (2924)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
It was reported that a thermal event at the mains power socket of the anesthetic gas vaporizer occurred which caused a short circuit resulting in shut-down of electric power for the entire or.There was no patient injury reported.
 
Event Description
It was reported that a thermal event at the mains power socket of the anesthetic gas vaporizer occurred which caused a short circuit resulting in shut-down of electric power for the entire or.There was no patient injury reported.
 
Manufacturer Narrative
The investigation revealed that the vaporizer was not connected to the auxiliary power outlets of the anesthesia workstation as intended.Instead the device was connected to a mains outlet socket of the hospital¿s electrical energy supply system by the original power cord and an additional extension cable.Due to routing on the floor, the protection against accidental disconnection or ingress of liquids was not ensured anymore.The available information indicates that plug and socket of the connection between power cable and extension cable became slightly loose, leading to reduced contact surface and increase in current density which resulted in overheating and the reported thermal event, finally.Hence, the event was not related to a deficiency of the product but to an inadequate installation of the electrical energy supply.This was also was substantiated by the subsequent inspection of the vaporizer which did not exhibit any deviations during testing.
 
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Brand Name
D-VAPOR
Type of Device
ANESTHESIA UNIT VAPORIZERS
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 Key12680174
MDR Text Key280515765
Report Number9611500-2021-00434
Device Sequence Number1
Product Code CAD
Combination Product (y/n)N
PMA/PMN Number
K042276
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 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberM35500
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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