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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 Device Displays Incorrect Message (2591)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2021.Date of report: 11mar2021.
 
Event Description
The customer reported there was an error in the touch panel.The field service engineer (fse) confirmed the reported failure.The (fse) calibrated the touch screen; however, the phenomenon did not improve; therefore, the touch screen was replaced.The unit was not in use, and there was no patient or user harm reported.
 
Manufacturer Narrative
The touchscreen was returned to the manufacturer for evaluation.The customer complaint cannot be verified.After calibration, all buttons respond normally.No-fault found.
 
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Brand Name
V60 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
MDR Report Key11467257
MDR Text Key241434562
Report Number2031642-2021-00932
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838033832
UDI-Public(01)00884838033832
Combination Product (y/n)N
PMA/PMN Number
K102985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberV60
Device Catalogue Number1076709
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2021
Was the Report Sent to FDA? No
Date Manufacturer Received05/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2019
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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