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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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RESPIRONICS, INC. BIPAP A40; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE Back to Search Results
Model Number R1111177
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/25/2023
Event Type  malfunction  
Event Description
The manufacturer received information alleging an x was continuously displayed on the device screen.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, a "ventilator inoperative" alarm code was found in the ventilator's downloaded error log.The humidifier also did not become warm.The device's main board was replaced to address the issue.The humidifier 6-pin harness was also replaced preventatively.
 
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Brand Name
BIPAP A40
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, 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
6501 living place
pittsburgh, PA 15208
4125423300
MDR Report Key18043864
MDR Text Key327481582
Report Number2518422-2023-28184
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K121623
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
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
Device Model NumberR1111177
Device Catalogue NumberR1111177
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2023
Initial Date Manufacturer Received 10/04/2023
Initial Date FDA Received10/31/2023
Date Device Manufactured08/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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