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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 Problems Intermittent Loss of Power (4016); Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 15sep2020.
 
Event Description
It was reported to philips that the device turned on/off automatically.The device was not being used on a patient at the time of the event.There was no patient or user harm reported.
 
Manufacturer Narrative
The device was reported to be ready for immediate use on a patient at the time of the event.The customer substituted the ventilator with a standby ventilator.There was no patient or user harm reported.A philips field service engineer (fse) was dispatched to the customer site.The reported issue was confirmed and traced to a faulty power management printed circuit board assembly (pm pcba).The fse replaced the pm pcba.The device passed performance verification testing and was placed back into service.
 
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Brand Name
V60 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
MDR Report Key10538314
MDR Text Key208119797
Report Number2031642-2020-03288
Device Sequence Number1
Product Code MNT
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 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2020
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? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2014
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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