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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 Display or Visual Feedback Problem (1184)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 22april2019.A follow-up report will be submitted once the investigation has been completed.
 
Event Description
Customer contacted technical support (ts) stating that unit had error code message of 3.3v voltage rail failed.The device was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or user.Event date not specified; estimate used.
 
Manufacturer Narrative
Adverse event or product problem: correction: product problem.Date rec'd by mfr: 25apr2019.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
G4: 10oct2019; b4: 11oct2019.Per service engineer, the customer reported problem was not duplicated.The unit passed functional testing.Cosmetic parts main housing and front display were replaced.The harmony muffler was found to be broken and replaced.The unit was returned to the customer.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 had error code message of 3.3v voltage rail failed.The device was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or user.Event date not specified; estimate used.
 
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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 Key8537461
MDR Text Key142748567
Report Number2031642-2019-02331
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 foreign,user facility
Type of Report Initial,Followup,Followup
Report Date 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
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 03/28/2019
Initial Date FDA Received04/22/2019
Supplement Dates Manufacturer Received03/28/2019
03/28/2019
Supplement Dates FDA Received04/25/2019
10/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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