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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) 2019.Date of report: 01april2019.A follow-up report will be submitted once the investigation is completed.
 
Event Description
The customer contacted philips technical support (ts) stating that unit had an error message of over pressure condition.The customer reported there was no patient involvement.The event date was not specified; estimate used.
 
Manufacturer Narrative
Date of report received: 11 jul 2019.Mfr received date: 09 jul 2019.The manufacturer¿s field service engineer (fse) remotely confirmed the reported over pressure condition issue.The manufacturer¿s field service engineer (fse) advised customer if no kinks to replace the flow valve assembly.Provided part number for service cd with calibration software.Discussed the calibration of the device.Provided customer with service manual.Customer confirms parts took care of the issue.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 Key8470216
MDR Text Key140517269
Report Number2031642-2019-01936
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
Type of Report Initial,Followup
Report Date 03/11/2019
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 Other
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/11/2019
Initial Date FDA Received04/01/2019
Supplement Dates Manufacturer Received03/11/2019
Supplement Dates FDA Received07/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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