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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, USA
Device Problem Defective Alarm (1014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/18/2022
Event Type  malfunction  
Event Description
The customer reported an error of 76 tcb buzzer super cap failure.Outside of use, no patient or user harm reported.The remote service engineer advised the customer that unit is no longer supported and emailed an end of life (eol) letter.
 
Manufacturer Narrative
The ventilator has been discontinued from use.The root cause is unknown.
 
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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
Manufacturer (Section G)
RESPIRONICS CALIFORNIA, LLC
2271 cosmos court
carlsbad CA 92011
Manufacturer Contact
melissa abbott
2271 cosmos court
carlsbad, CA 92011
7609187300
MDR Report Key13691129
MDR Text Key286949371
Report Number2031642-2022-00610
Device Sequence Number1
Product Code MNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053168
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBI-PAP FOCUS SYSTEM, USA
Device Catalogue Number1028772
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/02/2022
Date Device Manufactured07/26/2006
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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