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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 Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 26apr2019.A follow-up report will be submitted once the investigation has been complete.
 
Event Description
Customer contacted technical support (ts) stating that unit was blowing warm air out of the device.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
Date rec¿d by mfr: 26sep2019.Date of report: 01oct2019.The customer who is trying to decide whether it is worth repairing his 11 year old focus.The customer reported that the patient says that it is blowing warm.No patient harm was reported.Attempts were made to obtain further information regarding the device repair information.To date no further details have been received.The service history record was reviewed and no repair information was found.Per product support no further calls were raised against this focus so the likelihood is that the device was removed from service.No further information available from 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 was blowing warm air out of the device.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 Key8556864
MDR Text Key143475076
Report Number2031642-2019-02492
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
Report Date 04/04/2019
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 04/04/2019
Initial Date FDA Received04/26/2019
Supplement Dates Manufacturer Received04/04/2019
Supplement Dates FDA Received10/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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