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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 Intermittent Loss of Power (4016)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2018.Date of report: 07/01/2019.The manufacturer's field service engineer (fse) was dispatched to the site and confirmed the reported problem.The fse replaced the printed circuit board assembly (pcba), tahoe user interface and battery.The device was then found to be within manufacturer's specifications.
 
Event Description
The customer reported a ventilator that is turning on and off.This event was reported to have occurred during clinical use.However, there was no harm to the patient or user.
 
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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 Key8751323
MDR Text Key150262311
Report Number2031642-2019-04184
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 Biomedical Engineer
Type of Report Initial
Report Date 03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/29/2018
Initial Date FDA Received07/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/10/2007
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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