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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 Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 03june2019.A follow up report will be submitted once the evaluation is complete.
 
Event Description
The customer reported the unit's blower is not running.No patient or user harm was reported.
 
Manufacturer Narrative
G4: 08oct2019; b4: 08oct2019.After numerous attempts to obtain information on the repair of this device, this complaint is being closed.If further information is obtained, this complaint will be reopened.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 Key8761315
MDR Text Key150148723
Report Number2031642-2019-04246
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 06/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/20/2019
Initial Date FDA Received07/03/2019
Supplement Dates Manufacturer Received06/20/2019
Supplement Dates FDA Received10/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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