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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BREAS MEDICAL AB BREAS VIVO 50; RESPIRATORY THERAPY DEVICE (HOMECARE USE)
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BREAS MEDICAL AB BREAS VIVO 50; RESPIRATORY THERAPY DEVICE (HOMECARE USE) Back to Search Results
Model Number BREAS VIVO 50
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/16/2021
Event Type  malfunction  
Event Description
Fault description per the reporter "according to the nurse there was a loud bang this morning and afterwards the device gave several error codes (18,39 and 43).Case is broken at some bushings".There was no patient injury.
 
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Brand Name
BREAS VIVO 50
Type of Device
RESPIRATORY THERAPY DEVICE (HOMECARE USE)
Manufacturer (Section D)
BREAS MEDICAL AB
foretagsvagen 1
molnlycke, 43533
SW  43533
Manufacturer (Section G)
BREAS MEDICAL AB
foretagsvagen 1
molnlycke, 43533
SW   43533
Manufacturer Contact
elisabeth carlsson
foretagsvagen 1
molnlycke, 43533
SW   43533
MDR Report Key11590045
MDR Text Key244183667
Report Number9617566-2021-00002
Device Sequence Number1
Product Code NOU
UDI-Device Identifier07321822150005
UDI-Public7321822150005
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K123144
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBREAS VIVO 50
Device Catalogue Number215000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2021
Date Manufacturer Received03/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2014
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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