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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 No Display/Image (1183)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 08oct2020.
 
Event Description
The customer called technical support (ts) reporting that when turning on the device for pre-use check, the power lamp illuminated but the screen remained dark and didn't operate.The unit failed to turn off.The customer reported there was no patient involvement at the time the issue was discovered.
 
Manufacturer Narrative
G4:30dec2020.B4:15jan2021.The power management board assembly was returned for evaluation.The customer complaint was verified.The root cause was a failure of ic u11chip and transistors q12 and q16.Due to the nature of the failure, it is not possible to determine which of these components failed first.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 Key10649406
MDR Text Key211467997
Report Number2031642-2020-03632
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 09/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2020
Was the Report Sent to FDA? No
Date Manufacturer Received09/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/03/2013
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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