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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 Problems No Audible Alarm (1019); No Display/Image (1183); Device Displays Incorrect Message (2591); Unexpected Shutdown (4019)
Patient Problem Low Oxygen Saturation (2477)
Event Date 06/27/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 08jul2020.
 
Event Description
A customer reported to philips that while delivering therapy to a patient, the v60 ventilator had a full spontaneous shutdown with no audible alarm and the ventilator screen was black with a "blower failure" error message being displayed.While the device shutdown during therapy delivery, the patient experienced an event of oxygen desaturation to 70%, and the patient was placed on another ventilator.
 
Manufacturer Narrative
G4: (b)(6) 2020, b4: (b)(6) 2020.Correction:to mark the record as adverse event and product problem and as serious injury.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 Key10248542
MDR Text Key198693923
Report Number2031642-2020-02295
Device Sequence Number1
Product Code MNT
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 06/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? Yes
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 Received06/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
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