MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40 SYSTEM SILVER; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT

Model Number R1111177

Device Problem Operating System Version or Upgrade Problem (2997)

Patient Problem Unspecified Respiratory Problem (4464)

Event Type  Injury  

Event Description

The manufacturer received information alleging a ventilator inoperative condition occurred.The patient required manual ventilation and hospitalization.The ventilator was returned to the manufacturer for evaluation.The occurrence of a ventilator inoperative alarm due to e-86 was confirmed in the drpt.Evidence of adhesion of waterdrops to the main board was confirmed.The main board was replaced.Since life related smell was confirmed, the keypad was replaced.The manufacturer confirmed that the issues were resolved by replacing the parts above.Units were checked overall, cleaned, and functionally tested.The software version was upgraded to 3.6.5.

• Brand Name: BIPAP A40 SYSTEM SILVER
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18022194
• MDR Text Key: 326743006
• Report Number: 2518422-2023-27999
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: R1111177
• Device Catalogue Number: R1111177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 34 YR
• Patient Sex: Male