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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

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RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE Back to Search Results
Model Number V60
Device Problem Moisture or Humidity Problem (2986)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 02jul2020.
 
Event Description
The customer reported that there is water in the machine.There was no patient involvement.
 
Manufacturer Narrative
G4: 19oct2020 b4: 20oct2020 the humidifier failed causing too much rain out, the v60 unit was tested and no failures were identified with the unit.No malfunction occurred with the device.Based on this information the pr will be non-reportable.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
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
MDR Report Key10227403
MDR Text Key197906670
Report Number2031642-2020-02265
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838025776
UDI-Public(01)00884838025776
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
Report Date 06/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberV60
Device Catalogue Number1076716
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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