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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 BIPAP FOCUS SYSTEM, INT'L, RENTAL
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2021
Event Type  malfunction  
Event Description
The customer reported the unit gave a battery alarm error message.The device was not in use on a patient.No patient or user harm was reported.The customer confirmed the reported failure.The remote service engineer (rse) advised the unit is end of life (eol) with no service and limited parts available.Further information is pending.
 
Manufacturer Narrative
The battery was replaced, and the unit was tested and returned to service.The replaced battery was scrapped by the customer, no further investigation possible.
 
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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 Key12858160
MDR Text Key283247702
Report Number2031642-2021-05588
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 Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBIPAP FOCUS SYSTEM, INT'L, RENTAL
Device Catalogue NumberR1033869
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/21/2022
Date Device Manufactured02/28/2008
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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