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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
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 28may2020.
 
Event Description
It was reported when the unit was powered on an alarm sounded for over voltage protection.There was no patient involvement.
 
Manufacturer Narrative
G4: 18jun2020.B4: 18jun2020.The international service technician evaluated the unit and the over voltage protection alarm was confirmed in the significant event log though it was not able to be duplicated.The technician replaced the motor controller board and resolved the problem.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
G4:23nov2020, b4:11dec2020.The motor controller (mc) pcba was received for internal failure analysis.The mc pcba was tested and no failures were identified.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 Key10099197
MDR Text Key193400263
Report Number2031642-2020-01893
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,Followup
Report Date 05/11/2020
1 Device 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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/11/2020
Initial Date FDA Received05/28/2020
Supplement Dates Manufacturer Received05/11/2020
05/11/2020
Supplement Dates FDA Received06/18/2020
12/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
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