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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 Protective Measures Problem (3015)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 27jul2020.
 
Event Description
The customer reported a ventilator with a carbon dioxide detection alarm.This alarm was alleged to have occurred three times.This event was reported to have occurred during clinical use.There was no allegation of harm associated with this event.
 
Manufacturer Narrative
G4: 20oct2020, b4: 21oct2020.Upon investigation it was determined that this complaint is a duplicate of an existing complaint, for which mfr report #2031642-2020-02363 was already submitted.All information will be submitted under the initially reported mfr.Report #:2031642-2020-02363.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 Key10327203
MDR Text Key201155652
Report Number2031642-2020-02511
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 user facility
Type of Report Initial,Followup
Report Date 07/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2020
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 Received07/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
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