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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING Back to Search Results
Device Problem Protective Measures Problem (3015)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6).Date of report: 30aug2019.
 
Event Description
The customer reported a ventilator with a software anomaly alarm.There was no patient involvement / harm.
 
Manufacturer Narrative
Date rec'd by mfr: 30aug2019.Date of report: 26sep2019.The manufacturer's field service engineer confirmed the reported problem.The manufacturer's field service engineer reloaded the software, performed the system calibration and performance verification testing, and all testing was passed.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.
 
Event Description
The customer reported a ventilator with a software anomaly alarm.There was no patient involvement / harm.
 
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Brand Name
BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM
Type of Device
VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
MDR Report Key8950008
MDR Text Key178533255
Report Number2031642-2019-07684
Device Sequence Number1
Product Code MNS
Combination Product (y/n)N
PMA/PMN Number
K053168
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 08/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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