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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40 SYSTEM; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT
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RESPIRONICS, INC. BIPAP A40 SYSTEM; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT Back to Search Results
Model Number R1111177
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2023
Event Type  malfunction  
Event Description
The manufacturer received information alleging a ventilator inoperative condition occurred.There was no harm or injury reported.The device was checked by a philips service engineer.During the evaluation, the vent inop was confirmed.The main pca was replaced to address the reported issue.In addition, the blower was replaced for periodic maintenance.
 
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Brand Name
BIPAP A40 SYSTEM
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT
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
melissa rosko
6501 living place
pittsburgh, PA 15208
4125423300
MDR Report Key19214613
MDR Text Key341413338
Report Number2518422-2024-23776
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 User Facility
Reporter Occupation Other
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 Other
Device Model NumberR1111177
Device Catalogue NumberR1111177
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2023
Initial Date Manufacturer Received 08/04/2023
Initial Date FDA Received04/30/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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