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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE Back to Search Results
Model Number V60 VENT, CHINA OPT: CFLEX, AVAPS
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/03/2021
Event Type  malfunction  
Manufacturer Narrative
Report date: 16jun2021.
 
Event Description
It was reported to philips that the device had a no tidal volume.The device was reported as being in use at the time of the event on a patient.There was no patient or user harm reported.
 
Manufacturer Narrative
B4:02sep2021.An authorized service personnel (asp) was dispatched to the customer site.It was determined that the gas delivery system (gds) needed to be replaced to return the device to working condition.The asp replaced the gds to resolve the reported issue.The device passed performance verification testing.
 
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Brand Name
RESPIRONICS
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
MDR Report Key12010967
MDR Text Key256697848
Report Number2031642-2021-04112
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838025776
UDI-Public00884838025776
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberV60 VENT, CHINA OPT: CFLEX, AVAPS
Device Catalogue Number1076716
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date06/03/2021
Date Manufacturer Received06/03/2021
Date Device Manufactured06/26/2019
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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