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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) 2018.Date of report: 18sep2019.Manufacturer's field service engineer (fse) performed troubleshooting and advised customer to try ordering harmony valve.This mdr has been reassessed as reportable after a request from the fda on march 1, 2019 to review complaints from 29 nov 2017 to 29 nov 2018.As this has been reassessed, it will appear to be a late mdr.
 
Event Description
Customer reported over pressure condition error appearing on screen.There was no patient involvement.
 
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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
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
melissa abbott
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key9083015
MDR Text Key191982863
Report Number2031642-2019-09682
Device Sequence Number1
Product Code MNS
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K053168
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2019
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
Date Manufacturer Received11/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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