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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 Problems Crack (1135); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 03/12/2019.A follow-up report will be submitted once the investigation has been completed.
 
Event Description
Customer contacted technical support (ts) stating that unit won't work, has a cracked case, and missing the ac adapter.The customer reported there was no patient involvement.Event date not specified; estimate used.
 
Manufacturer Narrative
Date of report received: 28 jun 2019.Mfr received date: 27 jun 2019.The customer was ad vised to replace the power supply to address the reported issue of the missing alternate current (ac) adapter.To date the customer has not been able to be reached for further updates or repair information.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.Customer could not be reached.
 
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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 Key8414762
MDR Text Key138697074
Report Number2031642-2019-01462
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,user faci
Type of Report Initial,Followup
Report Date 02/15/2019
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 Health Professional
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/15/2019
Initial Date FDA Received03/12/2019
Supplement Dates Manufacturer Received02/15/2019
Supplement Dates FDA Received06/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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