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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 Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
Customer contacted technical support (ts) stating that unit failed performance verification testing (pvt) for pressure accuracy testing.The customer reported there was no patient involvement.Event date not specified; estimate used.
 
Manufacturer Narrative
Date of report: 25sep2019.This device problem occurred during reuse of the unit.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.
 
Manufacturer Narrative
Date received by manufacturer: 23mar2019.Report date: 25sep2019.The customer found pressure (p1) is pressure transducer mounted on the controller board faulty.The product support engineer advised customer that the controller board, is obsolete with no replacement.The product support provided customer end of life/end of service (eol/eos) documents for focus and controller board.Submission of a report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
Customer contacted technical support (ts) stating that unit failed performance verification testing (pvt) for pressure accuracy testing.The customer reported there was no patient involvement.Event date not specified; estimate used.
 
Event Description
Customer contacted technical support (ts) stating that unit failed performance verification testing (pvt) for pressure accuracy testing.The customer reported there was no patient involvement.Event date not specified; estimate used.
 
Manufacturer Narrative
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
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 Key8538141
MDR Text Key142754795
Report Number2031642-2019-02357
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 health professional,user faci
Type of Report Initial,Followup,Followup,Followup
Report Date 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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