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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 Inaccurate Flow Rate (1249)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 23jul2020.
 
Event Description
Customer contacted technical support (ts) stating that unit flow and volume values are not correct.The customer reported there was no patient involvement at the time the issue was discovered.
 
Manufacturer Narrative
G4: 30dec2020.B4: 11jan2021.The device was not being used for treatment when the reported event occurred.The manufacturer's product service engineer (pse) was dispatched to the site and confirmed the reported problem.The customer replaced the gas delivery system (gds) without data acquisition (da) printed circuit board assembly (pcba) to resolve the reported issue and the ventilator is back in service.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 Key10317111
MDR Text Key201016592
Report Number2031642-2020-02472
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberV60
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/12/2014
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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