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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LÖWENSTEIN MEDICAL TECHNOLOGY GMBH + CO. KG LUISA; Ventilator, continuous, facility use
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LÖWENSTEIN MEDICAL TECHNOLOGY GMBH + CO. KG LUISA; Ventilator, continuous, facility use Back to Search Results
Model Number LM150TD
Device Problem Fail-Safe Did Not Operate (4046)
Patient Problem Hypoxia (1918)
Event Date 07/18/2023
Event Type  malfunction  
Event Description
Lmt received information about a failure/interruption during therapy with our ventilator luisa in a clinic.According to the clinic, the patient was moved to another room and the power supply went to battery mode.After the room was changed, the power supply was reconnected to the socket in the room.The failure of the device occurred shortly afterwards when no staff was present.A member noticed that the unit had gone off without any alarm message/sound.The patient had to be ventilated manually and was connected to another ventilator.Lmt has not received any information about consequential damage.
 
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Brand Name
LUISA
Type of Device
Ventilator, continuous, facility use
Manufacturer (Section D)
LÖWENSTEIN MEDICAL TECHNOLOGY GMBH + CO. KG
kronsaalsweg 40
hamburg, hamburg 22525
GM  22525
Manufacturer (Section G)
LÖWENSTEIN MEDICAL TECHNOLOGY GMBH + CO. KG
kronsaalsweg 40
hamburg, hamburg 22525
GM   22525
Manufacturer Contact
christoph lemke
kronsaalsweg 40
hamburg, hamburg 22525
GM   22525
MDR Report Key18265361
MDR Text Key329688254
Report Number1000537145-2023-00011
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 07/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberLM150TD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Disability;
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