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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40 PRO; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC. BIPAP A40 PRO; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number CAX3100S12
Device Problem Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2023
Event Type  malfunction  
Event Description
The manufacturer received information alleging a ventilator had an internal pressure regulation issue that occurred.There was no harm or injury reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
 
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Brand Name
BIPAP A40 PRO
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
kimberly shelly
1001 murry ridge lane
murrysville, PA 15668
7247330200
MDR Report Key18502028
MDR Text Key332764879
Report Number2518422-2024-02162
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00606959059405
UDI-Public00606959059405
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K121623
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/12/2024
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
Device Model NumberCAX3100S12
Device Catalogue NumberCAX3100S12
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2023
Initial Date Manufacturer Received 12/27/2023
Initial Date FDA Received01/12/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/30/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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