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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

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V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE Back to Search Results
Model Number V60
Device Problem Energy Output Problem (1431)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 11sep2020.
 
Event Description
It was reported that the ventilator had a voltage supply failure.There was no patient involvement.The customer troubleshot with technical support and found error codes indicating a 3.3 volt failure, 5 volt supply failed and 35 volt failure.
 
Manufacturer Narrative
G4: 07oct2020; b4: 13oct2020.The service engineer (se) inspected the device.The se found the device was not showing voltage.The se reported that there was no issue with the power management board and replaced the motor controller board and power supply per the customer request to ensure no further issues.The unit was checked overall, run in tested, cleaned, functionally tested and no abnormality was confirmed.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
Manufacturer Narrative
G4: 07jan2021.B4: 08jan2021.Review of the ventilator diagnostic report found error codes indicating over voltage protection (ovp) circuit failed, motor controller printed circuit board assembly analog to digital converter (adc) failed, blower temperature high and blower temperature too high.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
Manufacturer Narrative
G4:30dec2020 b4: (b)(6) 2021 a power supply was returned for analysis.A visual inspection of the returned component was performed, no notable conditions were found.An investigation was performed and the product analysis technician reported that the root cause was due to the power supply component not having output.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
V60 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
MDR Report Key10523420
MDR Text Key207715747
Report Number2031642-2020-03233
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838020054
UDI-Public(01)00884838020054
Combination Product (y/n)N
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberV60
Device Catalogue Number1053617
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/21/2020
Initial Date FDA Received09/11/2020
Supplement Dates Manufacturer Received08/21/2020
08/21/2020
08/21/2020
Supplement Dates FDA Received10/13/2020
01/06/2021
01/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2016
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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