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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40 SYSTEM SILVER; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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RESPIRONICS, INC. BIPAP A40 SYSTEM SILVER; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING Back to Search Results
Model Number R1111177
Device Problem Circuit Failure (1089)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2020
Event Type  malfunction  
Event Description
The manufacturer received information alleging a bipap a40 system silver ventilator inoperative condition occurred.There was no harm or injury reported.The ventilator was returned to the manufacturer for evaluation and the customer¿s complaint was not confirmed.Error code e-47 and e-118 was recorded in the event log.The device's main board was replaced to address the issue.
 
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Brand Name
BIPAP A40 SYSTEM SILVER
Type of Device
VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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 Key18901790
MDR Text Key337624935
Report Number2518422-2024-13828
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 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 Operator Lay User/Patient
Device Model NumberR1111177
Device Catalogue NumberR1111177
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/21/2020
Initial Date FDA Received03/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/28/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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