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

Model Number	GBX3100H19
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging "that overnight the niv machine (b)(6) faulted.Power stopped and patient woken feeling like they were suffocating, woke partner.Machine then beeped and turned itself back on.No alarms occurred around event.Working again post event with no evidence of error.Checked re.Standard troubleshooting - confirmed power cable was connected properly, and battery pack was also attached, no power cut at time of event either." the device has been returned to the manufacturer, but evaluation has not yet begun.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported received information alleging "that overnight the niv machine (a40 pro) faulted.Power stopped and patient woken feeling like they were suffocating, woke partner.Machine then beeped and turned itself back on.No alarms occurred around event.Working again post event with no evidence of error.Checked re.Standard troubleshooting - confirmed power cable was connected properly, and battery pack was also attached, no power cut at time of event either.".In this report corrected as- the device's event logs were reviewed by the manufacturer.The only malfunction identified was limited to a software error that was able to be investigated through observation of the event log itself.The identified error code was e-095, low priority thread lock, which was triggered by a failed data transfer within the software.E-095 is a reboot-level error in which, by design, the device is rebooted to rectify the low priority thread lock so therapy can safely resume with minimal interruption.This incident is not indicative of any new or increased patient risk, and residual risk remains acceptable.Section event date, describe event or problem, date received by mfg, evaluation method code grid, evaluation results code grid, conclusion code grid have been updated/corrected.

• Brand Name: BIPAP A40
• Common Device Name: 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 Key: 18032178
• Report Number: 2518422-2023-28077
• Device Sequence Number: 6074105
• Product Code: MNT
• UDI-Device Identifier: 00606959055087
• UDI-Public: 00606959055087
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: GBX3100H19
• Device Catalogue Number: GBX3100H19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown