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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING Back to Search Results
Model Number BI-PAP FOCUS SYSTEM, INT'L
Device Problem Computer Operating System Problem (2898)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/05/2021
Event Type  malfunction  
Manufacturer Narrative
Date of report: 29jul2021.(b)(4).It is unknown if the device was in patient use when this event occurred.Additional information has been requested.
 
Event Description
The customer reported failure message 67 and the device keeps peeping.The patient involvement information is unknown but has been requested.There was no report of patient or user harm.
 
Manufacturer Narrative
B4:10sep2021.The issue was observed during preventive maintenance testing prior to therapeutic application, the reported issue is not likely to cause or contribute to death or serious injury.
 
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Brand Name
RESPIRONICS
Type of Device
VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, LLC
2271 cosmos court
carlsbad CA 92011
MDR Report Key12248967
MDR Text Key264351331
Report Number2031642-2021-04451
Device Sequence Number1
Product Code MNS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
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 No Information
Device Model NumberBI-PAP FOCUS SYSTEM, INT'L
Device Catalogue Number1033869
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date07/05/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/29/2021
Supplement Dates Manufacturer Received08/30/2021
Supplement Dates FDA Received09/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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