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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 Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2021.Date of report: 02mar2021.
 
Event Description
The customer reported the touchscreen froze.The field service engineer (fse) confirmed that the screen froze after the touchscreen was calibrated.The fse replaced the touchscreen to resolve the issue.The unit was tested and it was returned to service.The unit was not in use, and there was no patient or user harm reported.
 
Manufacturer Narrative
The touchscreen assembly was returned to manufacturer to failure investigation (fi) for analysis.The ul_lr / ur_ll resistance are out of spec.Fault are found on this returned touchscreen.
 
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Brand Name
V60 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
MDR Report Key11402152
MDR Text Key242579023
Report Number2031642-2021-00797
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 07/13/2021
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 Number1076709
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/02/2021
Initial Date FDA Received03/02/2021
Supplement Dates Manufacturer Received06/09/2021
Supplement Dates FDA Received07/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/21/2018
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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