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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40 PRO; VENTILATOR,CONTINUOUS,MINIMAL VENTILATOR SUPPORT, FACILITY USE
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RESPIRONICS, INC. BIPAP A40 PRO; VENTILATOR,CONTINUOUS,MINIMAL VENTILATOR SUPPORT, FACILITY USE Back to Search Results
Model Number EEX3100S19
Device Problem Circuit Failure (1089)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2023
Event Type  malfunction  
Event Description
The manufacturer received information alleging a ventilator inoperative condition occurred.There was no harm or injury reported.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
 
Manufacturer Narrative
H3 other text : device not returned to the manufacturer.
 
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Brand Name
BIPAP A40 PRO
Type of Device
VENTILATOR,CONTINUOUS,MINIMAL VENTILATOR 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
melissa rosko
6501 living place
pittsburgh, PA 15208
4125423300
MDR Report Key19214108
MDR Text Key341402274
Report Number2518422-2024-23851
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00606959059139
UDI-Public00606959059139
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K121623
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
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 Model NumberEEX3100S19
Device Catalogue NumberEEX3100S19
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/22/2023
Initial Date FDA Received04/30/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/05/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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